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

Model Number	ETLW1610C156E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Numbness (2415)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant aui and endurant limb stent graft were implanted in the endovascular treatment of a 46mm aaa and 35mm right common iliac abdominal aortic aneurysm.It was reported that the patient presented emergently on the just over a month later, complaining of numbness in the lower extremities bilaterally.The physician confirmed the absence of a femoral pulse and identified an occlusion.Intervention was performed on the same date and the patient underwent a thrombectomy and the proximal end of the stent graft was relined with an aui etuf2514c102e stent graft.As per the physician the cause of the event can not be determined.No additional clinical sequelae were provided and the patient is fine.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10447071
• Report Number: 9612164-2020-03117
• Device Sequence Number: 3316967
• Product Code: MIH
• UDI-Device Identifier: 00643169467637
• UDI-Public: 00643169467637
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/25/2020

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: 04/27/2022
• Device Model Number: ETLW1610C156E
• Device Catalogue Number: ETLW1610C156E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/25/2020
• 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: Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 49