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

Model Number	ETLW1610C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994); Weakness (2145)
Date of Event	04/18/2020
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 ii bifurcate stent graft system was implanted in the endovascular treatment of a 42mm abdominal aortic aneurysm.One day previously the patient had a right femoral endarterectomy performed.The evar procedure reportedly went well and the patient was discharged the next day.Post-operatively nine days post the index procedure, the patient presented with leg pain and weakness.The patient had weak pulses.A ct was performed which showed a limb occlusion.The images revealed that the right endurant limb is severely compressed through the distal aorta.It was noted the distal aortic measured only 16 mm in diameter.As per the physician the cause of the event is the right limb being compressed through the distal aorta.No additional clinical sequalae were provided and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received: it was reported that the right femoral endarterectomy was performed during the evar procedure and not the day previously.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 10000147
• Report Number: 9612164-2020-01684
• Device Sequence Number: 19662843
• Product Code: MIH
• UDI-Device Identifier: 00643169467644
• UDI-Public: 00643169467644
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 05/25/2020

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: 01/29/2022
• Device Model Number: ETLW1610C124E
• Device Catalogue Number: ETLW1610C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 05/25/2020
• 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
• Patient Age: 78 YR