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

Model Number	ETBF3620C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: product id: e tlw1616c124e, serial/lot #: (b)(4), ubd: 14-feb-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received notification via technical services in which a patient representative wanted to return a monitor.It was reported that the patient's representative father passed and he had medtronic stent grafts implanted.It was stated that patient passed however did not mention the stent graft as the cause of death.It was noted that a endurant ii stent graft system had been implanted on the (b)(6) 2016.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12750388
• Report Number: 9612164-2021-04216
• Device Sequence Number: 4560475
• Product Code: MIH
• UDI-Device Identifier: 00613994991065
• UDI-Public: 00613994991065
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2018
• Device Model Number: ETBF3620C166E
• Device Catalogue Number: ETBF3620C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 11/04/2021
• 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: Death
• Patient Age: 84 YR