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

Model Number	ETEW2020C82E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Fistula (1862); Unspecified Infection (1930)
Date of Event	07/08/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Film evaluation summary; the exact cause of the reported infected aorta and resulting sepsis could not be determined from the returned films.The pre-implant films were not available for review.The returned films confirmed the reported disease progression of the aorta.During the 14- month implant duration there had been significant dilatation of the distal aorta, leading to distal stent graft migration and a resulting type ib endoleak.The source of the reported aortic infection could not be determined, and it is possible that the infection may have contributed to the disease progression.No stent graft integrity issues were observed in the returned films.Month and year valid.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an infrarenal ulcer.It was reported the patient presented with sepsis over a year later.Review of ct and the patient¿s history led the to a diagnosis of an infected aorta with disease progression of the distal aorta.The device was explanted as treatment a day later.It was reported that the patient has an aortoenteric fistula when the stent graft was removed, and the aorta and common iliac arteries were ligated during the procedure.It was reported post procedure the patient developed sepsis and had to be returned to the or for re-ligation of the right common iliac artery.The patient succumbed to sepsis and died a few days post procedure.The actual date of death is unknown.Per the physician the cause was due to possible infection and disease progression.No additional clinical sequelae were reported.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8854663
• Report Number: 9612164-2019-03203
• Device Sequence Number: 16767849
• Product Code: MIH
• UDI-Device Identifier: 00613994991393
• UDI-Public: 00613994991393
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2020
• Device Model Number: ETEW2020C82E
• Device Catalogue Number: ETEW2020C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/02/2019
• 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: Death; Required Intervention
• Patient Age: 56 YR