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

Catalog Number	RMT281214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/20/2018
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 endoleak and aneurysm enlargement.Additionally, users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2013 a patient underwent treatment of an abdominal aortic aneurysm measuring 59.9mm with gore® excluder® aaa endoprostheses.On (b)(6) 2013 a ct revealed the aneurysm measured 55mm.On (b)(6) 2014 a ct revealed the aneurysm measured 57mm.On (b)(6) 2017 a ct revealed the aneurysm measured 56mm.On (b)(6) 2018 a ct revealed the aneurysm measured 69.7mm.On (b)(6) 2018 the patient underwent angioembolism of a type ii endoleak.The angioembolism was unsuccessful.On (b)(6) 2018 the patient underwent percutaneous embolization of the endoleak.On (b)(6) 2019 a ct revealed the aneurysm measured 71mm.The event is ongoing.

• 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: 8458432
• Report Number: 3007284313-2019-00088
• Device Sequence Number: 3219091
• Product Code: MIH
• UDI-Device Identifier: 00733132610679
• UDI-Public: 00733132610679
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/11/2019

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: 06/30/2014
• Device Catalogue Number: RMT281214
• Device Lot Number: 9343332
• 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: 03/27/2019
• 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: 73 YR
• Patient Weight: 69