Pipeline Flex Embolization Device INDICATIONS, SAFETY, AND WARNINGS
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Medtronic, Inc. (“Medtronic”) offers RemoteView, which permits a user (“Programmer User”) of the Medtronic CareLink® 2090 Programmer (“Programmer”) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (“Remote Viewer”), including remote health care professionals or Medtronic representatives.
Limited License Grant. You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. You may not otherwise copy, use, modify, reverse engineer, decompile, disassemble, create derivative works based on, or integrate with other systems or programs the Licensed Software without the prior written consent of Medtronic. You shall have sole responsibility for any fees or charges, including service or data charges, incurred by you in connection with your use of the Licensed Software. You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation.
Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer.
“Active Remote Viewer” as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software.
By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User:
) Registration. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. All information that you provide in connection with such registration must be complete, accurate, and truthful. The user name and password are personal to you and must not be shared with anyone else. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password.
) Your Personal Information. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. You agree that Medtronic may store this personal information about you on a Medtronic server, including a server located in the United States of America.
) Session Key. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. “Session Key” as used herein means a unique token active for a limited period of time generated by the Remote Viewer. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session.
) Logging of Session Activity. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America.
) Active Remote Users. When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information.
) Availability. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time.
Permissions. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software.
Your Acknowledgements. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patient’s implanted cardiac device data, including any data on the Programmer. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. You also acknowledge that information from the Licensed Software is not an electronic medical record and use of the Licensed Software does not in any way relieve you from using your best medical judgment to determine a proper course of treatment for patients.
Security/Privacy of Patient Data. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information.
Reporting Issues and Feedback. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. If you submit any comments or ideas to Medtronic, in the absence of a separate agreement regarding such submissions, you grant to Medtronic an unrestricted, royalty-free, irrevocable license to use, reproduce, display, perform, modify, transmit, and distribute such ideas in any medium and agree that Medtronic is free to use them for any purpose. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Any maintenance and support services provided by Medtronic shall be at Medtronic’s sole discretion.
Limitations of Liability.
THE LICENSED SOFTWARE IS PROVIDED TO YOU “AS IS,” AND MEDTRONIC EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE AND YOUR USE THEREOF, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE.
Legal Compliance. You shall at all times use the Licensed Software in compliance with all applicable laws. You shall ensure that your installation and use of the Licensed Software complies with all applicable export and import laws, regulations, orders, and policies of the United States of America and any other applicable jurisdiction. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a “terrorist supporting” country, and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties.
Term, Termination, Modifications, and Support. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Medtronic may modify, amend, or terminate this Agreement at any time, including by providing notices or an updated version of this Agreement on a Medtronic website. Medtronic may modify, disable, or terminate your use or Medtronic’s support of the Licensed Software at any time, including by providing notices on a Medtronic website. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. At any time upon Medtronic’s request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. In addition, upon Medtronic’s request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction.
NayaMed International Sárl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Sárl. If the Licensed Software is used connection with NayaMed customers or devices, this Agreement shall be directly between you and NayaMed with respect to those uses.
The Pipeline™ Flex embolization device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline™ Flex embolization device is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.
Federal (USA) law restricts this device to sale, distribution and use by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.
1) Resheathing of the Pipeline™ Flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid. 2) Persons with known allergy to platinum or cobalt/chromium alloy (including the major elements platinum, cobalt, chromium, nickel, molybdenum or tungsten) may suffer an allergic reaction to the Pipeline™ Flex embolization device implant. 3) Person with known allergy to tin, silver, stainless steel or silicone elastomer may suffer an allergic reaction to the Pipeline™ Flex embolization device delivery system. 4) Do not reprocess or resterilize. Reprocessing and resterilization increase the risk of patient infection and compromised device performance. 5) Post-procedural movement (migration and/or foreshortening) of the Pipeline Flex Embolization Device implant may occur following implantation and can result in serious adverse events and/or death. 6) Factors which may contribute to post procedural device movement include (but are not limited to) the following: Failure to adequately size the implant (I.e., under sizing), Failure to obtain adequate wall apposition during the implant deployment, Implant stretching, Vasospasm, Severe vessel tapering, Tortuous anatomy 7) Delayed rupture may occur with large and giant aneurysms. 8) Placement of multiple Pipeline™ Flex embolization devices may increase the risk of ischemic complications. 9) Use in anatomy with severe tortuosity, stenosis or parent vessel narrowing may result in difficulty or inability to deploy the Pipeline Flex Embolization Device and can lead to damage to the Pipeline™ Flex Embolization Device and microcatheter. Refer to page 4 in the instructions for use for additional information. 10) Do not attempt to reposition the device after full deployment. 11) The benefits may not outweigh the risks of treatment of small and medium asymptomatic extradural intracranial aneurysms, including those located in the cavernous internal carotid artery. The risk of rupture for small and medium asymptomatic extradural intracranial aneurysms is very low if not negligible. 12) A decrease in the proportion of patients who achieve complete aneurysm occlusion without significant parent artery stenosis has been observed with the use of the device in the communicating segment (C7) of the internal carotid artery (47.4% (9/19 subjects in the PREMIER study at 1 year)), including those IAs fed by the posterior circulation or have retrograde filling. Ensure appropriate patient selection and weigh the benefits and risks of alternative treatments prior to use of this device for the treatment of intracranial aneurysms located in this region of the ICA. The following anatomical characteristics, associated with retrograde filling, should be carefully considered during procedural planning of C7 intracranial aneurysms: Observed PComm of fetal origin (A PCA of fetal origin is defined as a small, hypoplastic, or absent P1 segment of the PCA with the PComm artery supplying a majority of blood flow to the ICA); PComm overlapping with the aneurysm neck; and/or PComm branch arising from the dome of the aneurysm. 13) Pushing delivery wire without retracting the micro catheter at the same time will cause the open end braid to move distally in the vessel. This may cause damage to the braid or vessel. 14) Use in tortuous anatomy may result in difficulty or inability to deploy the Pipeline Flex Embolization Device and can lead to damage to the Pipeline Flex Embolization Device and microcatheter. To mitigate potential problems as a result of increased delivery forces, reduce the load in the system by: Unloading the microcatheter to the inner curves of vessel by pulling back on the system (i.e., the microcatheter and delivery wire together). Continue unloading the system until advancement of the device (inside the microcatheter is observed, while minimizing the distal tip movement prevent loss of position. Begin to re-advance the delivery wire while the device passes through tortuous area and the delivery force is decreased.
1) The Pipeline™ Flex embolization device should be used only by physicians trained in percutaneous, intravascular techniques and procedures at medical facilities with the appropriate fluoroscopy equipment. 2) Physicians should undergo appropriate training prior to using the Pipeline™ Flex embolization device in patients. 3) The Pipeline™ Flex embolization device is provided sterile for single use only. Store in a cool, dry place. Carefully inspect the sterile package and device components prior to use to verify that they have not been damaged during shipping. Do not use kinked or damaged components. Do not use product if the sterile package is damaged. 4) Use the Pipeline™ Flex embolization device system prior to the “Use By” date printed on the package. 5) The appropriate anti-platelet and anti- coagulation therapy should be administered in accordance with standard medical practice. 6) A thrombosing aneurysm may aggravate pre-existing, or cause new, symptoms of mass effect and may require medical therapy. 7) Use of implants with labeled diameter larger than the parent vessel diameter may result in decreased effectiveness and additional safety risk due to incomplete foreshortening resulting in an implant longer than anticipated. 8) The Pipeline™ Flex embolization device may create local field inhomogeneity and susceptibility artifacts during magnetic resonance angiography (MRA), which may degrade the diagnostic quality to assess effective intracranial aneurysm treatment. 9) Take all necessary precautions to limit X-radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible. 10) Carefully weigh the benefits of treatment vs. the risks associated with treatment using the device for each individual patient based on their medical health status and risks factors for intracranial aneurysm rupture during their expected life time such as age, medical comorbidities, history of smoking, intracranial aneurysm size, location, and morphology, family history, history of prior asymptomatic subarachnoid hemorrhage (aSAH), documented growth of intracranial aneurysm on serial imaging, presence of multiple intracranial aneurysms, and presence of concurrent pathology. The benefits of device use may not outweigh the risks associated with the device in certain patients; therefore, judicious patient selection is recommended. 11) The safety and effectiveness of the device has not been established for treatment of fusiform IAs. 12) There may be a decrease in effectiveness and increase in safety events when the device is used in patients ≥ 60 years old. 13) The safety and effectiveness of the device has not been evaluated or demonstrated for ruptured aneurysms.
Potential complications of the device and the endovascular procedure, include, but are not limited to the following: Adverse reaction to antiplatelet/ anticoagulation agents, anesthesia, reactions due to radiation exposure (such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia) or contrast media, including organ failure; Vascular Complications like vasospasm, stenosis, dissection, perforation, rupture, fistula formation, pseudo aneurysm, occlusion , thromboembolic complications including ischemia (to unintended territory); Device complications like fracture, breakage, misplacement, migration / delayed forshortening or reaction to device materials; Systemic Complications like: Infection, Pain, fever, allergic reactions, organ failure, nerve damage; Bleeding/ hemorrhagic complication including retroperitoneal hemorrhage; Neurological Deficits or dysfunctions including Stroke, Infarction, Loss of vision, Seizures, TIA, Headache, Cranial Nerve Palsies, Confusion, Coma; Decreased therapeutic response including need for target aneurysm retreatment; Risks associated with visual symptoms include Amaurosisfugax/transient blindness, Blindness, Diplopia, Reduced visual acuity/field, Retinal artery occlusion, Retinal ischemia, Retinal infarction, Vision impairment including scintillations, blurred vision, eye floaters; Intra-Cranial Hemorrhage (including from Aneurysm Rupture) Brain Edema, Hydrocephalus, Mass Effect; Death.
1) Patients with active bacterial infection. 2) Patients in whom dual antiplatelet and/or anticoagulation therapy (aspirin and clopidogrel) is contraindicated. 3) Patients who have not received dual antiplatelet agents prior to the procedure. 4) Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. 5) Patients in whom the parent vessel size does not fall within the indicated range.
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