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

Catalog Number	RMT281418
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/04/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to stent fracture.
Event or Problem Description
On (b)(6) 2014, this patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis featuring c3® delivery system.On (b)(6) 2014, 6 month imaging follow-up identified a wire fracture proximal to the flow divider of the trunk-ipsilateral component.On (b)(6) 2018, a 48 month imaging follow-up confirmed the wire fracture.
Event or Problem Description
On (b)(6) 2014, 6 month imaging follow-up identified a wire fracture proximal to the flow divider of the trunk-ipsilateral component.

• 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: 8174171
• Report Number: 2017233-2018-00770
• Device Sequence Number: 19519282
• Product Code: MIH
• UDI-Device Identifier: 00733132610730
• UDI-Public: 00733132610730
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: RMT281418
• Device Lot Number: 12402049
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR