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

Model Number	ETBF3216C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: e tlw1616c82e, serial/lot #: (b)(4), ubd: 25-sep-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted for the endovascular treatment of a 52mm abdominal aortic aneurysm.It was reported that the patient presented emergently fourteen days later with a pulseless right femoral artery and a ct and angiogram confirmed a limb occlusion.A secondary procedure was carried out and endurant aui stent graft was implanted and a femoral-femoral bypass carried out which resolved the occlusion.As per the physician the cause of the event is patient anatomy.The patient was reported to have a long narrow distal aorta with diameters of 27-28-25.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Film analysis: the exact cause of the reported limb occlusion could not be determined from the pre-implant films provided.The ct¿s returned were non-contrast; therefore, no assessment of vessel patency or thrombus could be performed.Images during implant were also not returned, and ct¿s/angiograms during the reported occlusion event were not available for assessment of the event and evaluation of the post-implant stent graft configuration.A returned pre-implant angiogram study during contrast injections and flow lumen evaluation revealed that the proximal neck likely contained significant thrombus.The flow lumen diameter measured ~20mm just below the right renal, and narrowed down to ~11mm near the distal end of the 50mm length proximal neck.It is possible that oversizing of the 32mm bifurcate within the thrombus filled aortic neck may have compressed the stent graft which subsequently contributed to the occlusion.Implanting within the long (40mm) and relatively narrow (23 ¿ 19mm flow lumen diameter) distal aorta may have also been a contributor.This may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 9551871
• Report Number: 9612164-2020-00070
• Device Sequence Number: 14318212
• Product Code: MIH
• UDI-Device Identifier: 00613994990990
• UDI-Public: 00613994990990
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 02/10/2020

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: 03/06/2021
• Device Model Number: ETBF3216C166E
• Device Catalogue Number: ETBF3216C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/10/2020
• 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: Required Intervention
• Patient Age: 70 YR