MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PLC231000
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Aneurysm (1708); Occlusion (1984)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.The device remains in the patient.The cause of vessel¿s occlusion was unknown.The physician was not certain how this happened, however, he was not concerned about this outcome.Reportedly, there was nothing in patient¿s anatomy caused or contributed to the event.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to occlusion of device or native vessel.
Event or Problem Description
On (b)(6), 2019, this patient underwent an endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.When deploying a gore® excluder® aaa endoprosthesis contralateral leg component, it was detected that the left internal iliac artery was unintentionally covered.Reportedly, an internal iliac artery ostium was visualized with contrast and marked.The length was measured with a pigtail catheter.A correct device was selected and deployed.The physician was not certain how this happened, however, he was not concerned about this outcome.Reportedly, there was nothing in patient¿s anatomy caused or contributed to the event.The device was extended into external iliac artery to secure sufficient purchase.The procedure was successfully completed.The right internal iliac artery preserved.The patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9419713
• Report Number: 3013164176-2019-00164
• Device Sequence Number: 16766851
• Product Code: MIH
• UDI-Device Identifier: 00733132618576
• UDI-Public: 00733132618576
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: 06/27/2022
• Device Catalogue Number: PLC231000
• Device Lot Number: 20779316
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2019
• 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: Hospitalization; Other