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

Catalog Number	RLT231216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications: amlodipine, lisinopril, and prednisone.
Event or Problem Description
On (b)(6) 2018, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.Reportedly the patient had friable anatomy.It was reported there was a shelf of calcium in the artery where the contralateral gate was going to open.The physician attempted to land and open the contralateral gate on the short side of the shelf of calcium.When the device was deployed, the contralateral gate was pinched.The physician made several attempts to fully open the contralateral gate, but could not get the gate to fully open, due to the shelf of calcium.The physician decided to perform an unplanned aui and a fem-to-fem bypass.The patient tolerated the procedure.

• 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: 7840469
• Report Number: 3007284313-2018-00247
• Device Sequence Number: 19216346
• Product Code: MIH
• UDI-Device Identifier: 00733132622344
• UDI-Public: 00733132622344
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2018

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: 11/12/2020
• Device Catalogue Number: RLT231216
• Device Lot Number: 17439750
• 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: 09/01/2018
• 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; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 81