MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RLT231214
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 component migration and occlusion.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis featuring c3® delivery system.The aortic neck was described as highly angulated, approximately 60 degrees.Percutaneous right femoral access was obtained.The trunk-ipsilateral leg component was advanced.The first stage of deployment was completed, seating the device just below the lowest renal artery.The cannulation of the contralateral gate was accomplished.A confirmation angio run was completed.It was noted the trunk-ipsilateral leg had migrated approximately 1cm.The device was reconstrained and positioned, then deployed.Upon another fluoro run, it was discovered the ipsilateral-leg on the right side had covered hypogastric artery.Additionally, the trunk-ipsilateral-leg component slipped again, distally.So a medtronic cuff was advanced and deployed to extend treatment to the lowest renal.The patient tolerated procedure and did well in follow-up.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8776357
• Report Number: 3007284313-2019-00200
• Device Sequence Number: 16613491
• Product Code: MIH
• UDI-Device Identifier: 00733132622337
• UDI-Public: 00733132622337
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/13/2019

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: 07/31/2021
• Device Catalogue Number: RLT231214
• Device Lot Number: 18419658
• 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: 07/10/2019
• 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; Required Intervention
• Patient Weight: 65