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

Catalog Number	PLC161000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified 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: endoleak and aneurysm enlargement.
Event or Problem Description
The following information was reported to gore: on an unknown date, a patient underwent endovascular treatment of an abdominal aortic aneurysm.On (b)(6) 2015 the aneurysm measuring 69mm.A gore® excluder® aaa endoprosthesis was implanted.On (b)(6) 2015 the aneurysm measured 68mm.On (b)(6) 2016 the aneurysm measured 69mm.On (b)(6) 2016 the aneurysm measured 70mm.On (b)(6) 2017 the aneurysm measured 71mm.On (b)(6) 2019 a reintervention was performed to treat a type ii endoleak whereby onyx embolization of the aaa sac was performed.A type ib endoleak was treated with distal extension on the right side.Additionally, a left femoral endarterectomy and patch angioplasty was performed.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8302960
• Report Number: 2953161-2019-00011
• Device Sequence Number: 986406
• Product Code: MIH
• UDI-Device Identifier: 00733132618668
• UDI-Public: 00733132618668
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: PLC161000
• Device Lot Number: 13930201
• 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: 02/04/2019
• 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 Age: 83 YR
• Patient Weight: 87