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

Model Number	ETUF2814C102E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/04/2020
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 an unknown size abdominal aortic aneurysm on the (b)(6) 2020.A non mdt stent graft was attempted to be implanted but failed due to an occluded left iliac and the physician elected to implant the aui.It was reported during the index procedure the endurant aui was implanted with an endurant limb extension (etlw1616c124e v29886412)) into the right iliac artery.During removal of the aui delivery system, the physician did not close the nose cone completely and some plaques were pulled out subsequently breaking some of the proglide stitches.The extension was then implanted and a fem fem bypass completed.Final angiogram was performed showing no endoleaks, blockages and no extravasation from the right external iliac.As per the physician, the cause of the event was due to user error.No additional clinical sequelae were reported and the patient is fine.

• 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 ; IE
• MDR Report Key: 10618484
• Report Number: 9612164-2020-03733
• Device Sequence Number: 11758567
• Product Code: MIH
• UDI-Device Identifier: 00643169232594
• UDI-Public: 00643169232594
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 10/02/2020

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: 12/19/2021
• Device Model Number: ETUF2814C102E
• Device Catalogue Number: ETUF2814C102E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 10/02/2020
• 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: 77 YR