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

Model Number	ENBF2813C145E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2011
Type of Reportable Event	Death
Event or Problem Description
An endurant stent graft system was implanted during an unknown endovascular procedure.It was reported 10 years post the index procedure via technical services from the patients daughter in law that the patient expired on the day of the index procedure.No cause of the event was provided.No additional clinical sequalae was provided and the patient has expired.
Additional Manufacturer Narrative
Concomitant medical products:relevant device(s) are: product id: e new1313c82e, serial/lot #:(b)(4), ubd: 19-aug-2013, udi#: (b)(4) ; product id: enlw1616c82e, serial/lot #: (b)(4), ubd: 18-jul-2013, udi#: (b)(4) ; product id: enlw1613c124e, serial/lot #: (b)(6), ubd: 06-sep-2013, udi#: (b)(6).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13248032
• Report Number: 9612164-2022-00186
• Device Sequence Number: 19950626
• Product Code: MIH
• UDI-Device Identifier: 00613994762207
• UDI-Public: 00613994762207
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2022

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: 07/19/2013
• Device Model Number: ENBF2813C145E
• Device Catalogue Number: ENBF2813C145E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/13/2022
• Date Device Manufactured: 07/25/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 84 YR
• Patient Sex: Male