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

Catalog Number	RLT231218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2017
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 (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleaks.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2015 a patient underwent treatment of an abdominal aortic aneurysm measuring 49.7mm in diameter with gore® excluder® aaa endoprostheses.On (b)(6) 2015 the aneurysm measured 48.2mm.On (b)(6) 2016 the aneurysm measured 45.7mm.On (b)(6) 2017 the aneurysm measured 46.1mm.On (b)(6) 2018 the aneurysm measured 52.1mm.On (b)(6) 2018 the aneurysm measured 58.6mm.On (b)(6) 2018 a reintervention was performed to treat the endoleak.A ct scan guided embolization was performed with onyx.On (b)(6) 2018 the aneurysm measured 58.3mm.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2015 a patient underwent treatment of an abdominal aortic aneurysm measuring 49.7mm in diameter with gore® excluder® aaa endoprostheses.On (b)(6) 2015 the aneurysm measured 48.2mm.On (b)(6) 2016 the aneurysm measured 45.7mm.On (b)(6) 2017 the aneurysm measured 46.1mm.On (b)(6) 2018 the aneurysm measured 52.1mm.On (b)(6) 2018 the aneurysm measured 58.6mm.On (b)(6) 2018 a reintervention was performed to treat a type ii endoleak.A ct scan guided embolization was performed with onyx.On (b)(6) 2018 the aneurysm measured 58.3mm.

• 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: 7988249
• Report Number: 2017233-2018-00633
• Device Sequence Number: 1530989
• Product Code: MIH
• UDI-Device Identifier: 00733132622351
• UDI-Public: 00733132622351
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 11/19/2018

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: 11/30/2017
• Device Catalogue Number: RLT231218
• Device Lot Number: 13366744
• 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: 10/20/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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; Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 67