MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II EXTENSION CUFF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number	ETEW2020C82E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a 64mm x 54mm abdominal aortic aneurysm.It was reported that during the index procedure, the right etlw1620c124e limb was placed short of anticipated landing zone and required a limb extension being placed.The left external iliac artery was dissected during access and a etew2020c82e stent was implanted to treat the dissection.Two days later, the patient presented emergently with cold pulseless legs.A cta was performed which showed the right iliac etlw1620c146e device was kinked and thrombosed, the left external iliac was thrombosed also.Intervention was performed, the physician performed bilateral femoral cutdowns and bilateral embolectomies.A non mdt stent was placed in the kinked right limb and then both limbs were ballooned at the same time to 16mms.It was reported, the cause of the dissection to the left external iliac was caused during access which the physician felt was a cause of inadequate visualization with fluoro unit and pt size.It was also reported, the 20 portion of the left limb was next to the 16 portion of the right limb and once the dissected left external iliac shut down it caused the pressure to increase in the left common iliac making the 20 portion compress the 16 portion of the right iliac limb.No additional clinical sequelae were provided and the patient is fine.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12201676
• Report Number: 9612164-2021-02815
• Device Sequence Number: 17200037
• Product Code: MIH
• UDI-Device Identifier: 00613994991393
• UDI-Public: 00613994991393
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: ETEW2020C82E
• Device Catalogue Number: ETEW2020C82E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 63 YR