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

Model Number	ETUF2514C102E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/03/2020
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 aui stent graft was implanted in the endovascular treatment of a 56mm abdominal aortic aneurysm.It was reported that during the index procedure, after deployment of the device, the delivery system became stuck proximally at the level of an existing stent.The delivery system would not advance into the abdominal aorta at this point.It was reported that the physician was unable to gain access for any adjunctive troubleshooting techniques.The decision was made to gain proximal access and dissect to the level of the proximal delivery catheter, the delivery system was then cutdown and removed successfully a non-mdt conduit graft was implanted at the right femoral artery.The remaining procedure was reported to be completed in the usual way and the patient remained stable throughout.As per the physician the cause of the event was anatomy.It was noted that the patient's peripheral artery disease, small calcified access and prior interventions would have contributed.No additional clinical sequalae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary from the limited images provided the delivery system removal difficulties could not be observed; therefore, the cause of the removal difficulties could not be determined.Procedural images showing the delivery system during insertion or removal were not provided for assessment of the devices trackability through the patients anatomy.The location of the existing rci stent could not be observed from the images provided.It is likely that the reported narrow, tapered and calcified right iliac access vessel contributed to the reported delivery system removal event.It is also likely that interaction with the existing rci stent within this challenging anatomy was may have been a factor in the occurrence of the event.Analysis of the returned films did not reveal any device issues that could explain the reported event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9665076
• Report Number: 9612164-2020-00555
• Device Sequence Number: 11624439
• Product Code: MIH
• UDI-Device Identifier: 00643169232570
• UDI-Public: 00643169232570
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/13/2020

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: 01/12/2022
• Device Model Number: ETUF2514C102E
• Device Catalogue Number: ETUF2514C102E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/13/2020
• 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: 56 YR
• Patient Weight: 63