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

Model Number	ETCF3232C49E
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Ischemia (1942); Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	02/21/2022
Type of Reportable Event	Death
Event or Problem Description
An aneurx bifurcate stent graft system was implanted in the endovascular treatment of 50mm abdominal aortic aneurysm.  it was reported on the date of a ct , a left iliac limb occlusion was noted.It was said the top of the graft looked to have migrated well below the renal arteries.The patient was experiencing leg ischemia. the current aneurysm diameter is noted as 64mm.It was reported that an intervention took place.An endurant aui and cuff was implanted landing at the left lowest renal artery and extended out with a endurant 16 x16x 56 limb into the existing right iliac limb, then proceeded with a fem-fem bypass.The physician was unable to determine if only main body or limbs changed position with migration.It was reported that the patient went to a hospice the following month and is now deceased.The exact date of death is unknown.Per the physician, the cause of death is unknown.No additional clinical sequelae were provided and the patient is expired.*additional information received 14-mar-2022: it was reported that the patient went to hospice in (b)(6) and is now deceased.The exact date of death is unknown.*additional information received 15-mar-2022: per the physician, the cause of death is unknown.
Additional Manufacturer Narrative
Other relevant device(s) are: product id: e tuf3214c102e, serial/lot #: (b)(4), ubd: 07-apr-2023, udi#: (b)(4).Product id: etlw1616c156e, serial/lot #: (b)(4), ubd: 19-apr-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• 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
• 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: 13962502
• Report Number: 9612164-2022-01245
• Device Sequence Number: 11803159
• Product Code: MIH
• UDI-Device Identifier: 00613994991454
• UDI-Public: 00613994991454
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/31/2022

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: 07/16/2022
• Device Model Number: ETCF3232C49E
• Device Catalogue Number: ETCF3232C49E
• 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: 03/04/2022
• Initial Report FDA Received Date: 03/31/2022
• Date Device Manufactured: 07/16/2020
• 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: Other; Required Intervention; Death
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 64 KG