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

Catalog Number	RMT311415
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing records verified that the lots involved in this event met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), complications associated with the use of the gore® excluder® aaa endoprosthesis may include but are not limited to: endoleaks.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2013, this patient underwent endovascular treatment for an abdominal aortic aneurysm (aaa) measuring 80 mm in diameter and was treated with gore® excluder® aaa endoprostheses.On (b)(6) 2017, ultrasound examination revealed an aneurysm diameter of 88 mm.On (b)(6) 2017, ultrasound examination identified an aneurysm diameter of 90 mm.On (b)(6) 2018, computed tomography angiography imaging confirmed an aneurysm diameter of 94 mm.On (b)(6) 2018, an additional graft was implanted during an endovascular procedure to treat a persisting type 1a or type ii endoleak.

• 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: 7941233
• Report Number: 2017233-2018-00593
• Device Sequence Number: 11100943
• Product Code: MIH
• UDI-Device Identifier: 00733132610754
• UDI-Public: 00733132610754
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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: 10/31/2014
• Device Catalogue Number: RMT311415
• Device Lot Number: 9752354
• 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: 10/06/2018
• 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: 78 YR
• Patient Weight: 103