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

Model Number	ETCF3636C49E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	03/20/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 89mm abdominal aortic aneurysm.It was reported that post-operatively a ct performed 2 years and 11 months later identified a type ia endoleak was present.It was reported that the aneurysm measured 7.5 cm x 8.9 cm.Intervention was performed just under a month later, a endurant aortic cuff etcf3636c49e was implanted along with the implantation of endoanchors.A 6x22 non-mdt( icast) was also placed in the left renal.Despite this the type ia endoleak was still present.As per the physician the cause of the event was anatomy and noted the aortic neck diameter had enlarged.It was reported the patient presented to the er with a ruptured aneurysm approximately four weeks post the re-intervention.A chimney was placed in the left renal artery and a endurant aortic cuff etcf3636c49e was implanted up to the right renal and sma.A chimney was then placed into the sma and covered the right renal artery, sma, and celiac artery with a valiant navion vnmf4343c103e stent graft and then placed another valiant navion vnmf4040c103e more proximally.A final angiogram showed the ia endoleak had resolved and the sma and left renal were perfused.The patient was then extubated that night and reported to be in a stable condition the next morning.The patient was being discharged from hospital four days later and it was reported when the patient got out of bed they collapsed suddenly, and cpr was performed.The patient subsequently expired.As per the physician the cause of death is unknown and there won¿t be an autopsy performed.No additional clinical sequalae were provided and the patient has expired.

• 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 ; IE
• MDR Report Key: 9942367
• Report Number: 9612164-2020-01535
• Device Sequence Number: 3752092
• Product Code: MIH
• UDI-Device Identifier: 00613994991461
• UDI-Public: 00613994991461
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2020

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: 04/05/2020
• Device Model Number: ETCF3636C49E
• Device Catalogue Number: ETCF3636C49E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/09/2020
• 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
• Patient Age: 84 YR