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

Catalog Number	RMT281416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 52 mm in diameter and was therefore implanted with gore® excluder® aaa endoprostheses.On (b)(6) 2012, follow-up computed tomography angiography imaging identified an aneurysm diameter of 45 mm.On (b)(6) 2017, follow-up ultrasound examination revealed an aneurysm diameter of 38 mm.On (b)(6) 2018, follow-up computed tomography angiography imaging confirmed an aneurysm diameter of 50 mm.The cause for the enlargement was stated to be unknown.There is no re-intervention planned at this time.

• 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: 8188777
• Report Number: 2017233-2018-00790
• Device Sequence Number: 19339493
• Product Code: MIH
• UDI-Device Identifier: 00733132610723
• UDI-Public: 00733132610723
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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: 12/31/2014
• Device Catalogue Number: RMT281416
• Device Lot Number: 9990574
• 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: 12/21/2018
• 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
• Patient Age: 82 YR
• Patient Weight: 94