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

Model Number	ETBF2513C166E
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Occlusion (1984); Claudication (2550)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis summary: the cause of the reported left limb compression resulting in the buttock and left thigh claudication could not be determined from the pre-implant ct¿s returned.Images during implant were not available and post-implant films showing the reported limb compression were not provided, and the reported event could not be assessed.It is possible that implanting within the small caliber and significantly calcified distal aorta may have led to the compression of the left limb by the right limb.The acutely angulated and calcified lcia may have also contributed to flow restrictions down the left side.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 53mm abdominal aortic aneurysm.It was reported that when the patient returned for follow-up four and a half months later that the patient complained of buttock and left thigh claudication.A ct was completed which revealed a compressed left limb etlw1613124e from pressure exerted by the right contralateral limb of the main body bifurcate stent graft.As per the physician the cause of the event is the right limb compressing the left limb.It was reported that the patient's ankle-br achial index (abi) reduced from 1.0 to 0.3 with the buttock and thigh claudication.No additional clinical sequalae were provided and the patient will be monitored.

• Brand Name: ENDURANT II BIFURCATED 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: 9864838
• Report Number: 9612164-2020-01300
• Device Sequence Number: 468927
• Product Code: MIH
• UDI-Device Identifier: 00613994991249
• UDI-Public: 00613994991249
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2021
• Device Model Number: ETBF2513C166E
• Device Catalogue Number: ETBF2513C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/23/2020
• 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: 79 YR