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

Model Number	ETCF2828C49E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the reported endoleaks could not be confirmed from the films provided; therefore the type and exact cause of the endoleak could not be determined.Procedural images or videos showing the implantation of the device and the reported type ia and type iv endoleaks were not provided.Additional images showing the interventional treatment with the endurant cuff and sma stenting were also not provided.It is possible that the severely angulated aortic neck may have been a contributory factor in the occurrence of the type ia endoleak.Type iv endoleaks most commonly occur during an index procedure due to fabric porosity and other factors such as heparin dose, outflow resistance, imaging quality, and volume of the aneurysm sac are also potential contributors.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant bifurcated stent graft system was implanted in the endovascular treatment of unknown size abdominal aortic aneurysm.It was reported that during the index procedure, a type ia endoleak was present upon completion angiogram.This leak was reported to be more prominent than the type iv endoleak that was present on the patients left.The physician reballooned the proximal neck but the endoleak persisted.It was then decided to place an endurant aortic cuff.This device deployed but in doing so it partially covered the superior mesenteric artery (sma).The sma was then cannulated and a non-mdt bare metal stent was implanted.On final angiogram the sma was patent and the procedure was completed.As per the physician the cause of the event is unknown.No additional clinical sequalae were reported and the patient is fine.

• Brand Name: ENDURANT II AORTIC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9699112
• Report Number: 9612164-2020-00684
• Device Sequence Number: 16596737
• Product Code: MIH
• UDI-Device Identifier: 00613994991447
• UDI-Public: 00613994991447
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 04/15/2020

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: 03/03/2021
• Device Model Number: ETCF2828C49E
• Device Catalogue Number: ETCF2828C49E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/15/2020
• 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: 65 YR
• Patient Weight: 81