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

Model Number	ETUF3614C102E
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/06/2019
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 a patient for the endovascular treatment of a 50 mm abdominal aortic aneurysm.It was reported that the patient has a very small access anatomy and a previously implanted bare metal stent in the right common iliac artery.It was reported that the device was initially unable to be passed due to the vessel size and disease.A series of dilations were performed throughout the access vessel, but the device still would not pass.In the process of dilating and trying to advance the delivery system the right femoral artery ruptured.The rupture was repaired.A different device was then used and was able to be passed successfully.The aneurysm was successfully treated.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the reported inability to position the device via the right access vessel and resulting vessel rupture could not be determined from the pre-implant films provided.Images during implant were not available for review and the reported events could not be assessed.However, it appears likely that numerous attempts to pass the device via the patient¿s pre-existing 7mm id rcia stent, and small caliber access vessels, likely contributed to the events.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: 9451007
• Report Number: 9612164-2019-05109
• Device Sequence Number: 3067438
• Product Code: MIH
• UDI-Device Identifier: 00643169232631
• UDI-Public: 00643169232631
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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: 01/02/2020
• Device Model Number: ETUF3614C102E
• Device Catalogue Number: ETUF3614C102E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2019
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/15/2020
• 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: 82 YR