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

Model Number	RMT311417
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm (1708); No Code Available (3191)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Additionally, per ifu, adverse events that may occur and / or require intervention include, but are not limited to endoleak and aneurysm enlargement. .
Event or Problem Description
It was reported that on (b)(6) 2011, the patient presented with a 55 mm abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprostheses.Follow-up imaging showed that the aneurysm size appeared to be stable until (b)(6) 2017 (52 mm).Aneurysm growth to 60 mm was visible on (b)(6) 2018.Continuous aneurysm growth to 65 mm was identified on (b)(6) 2019.On (b)(6) 2019, a type ii endoleak of unspecified origin was identified and successfully treated with embolization on (b)(6) 2019.The patient tolerated the procedure.

• 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: 10194069
• Report Number: 3007284313-2020-00159
• Device Sequence Number: 14028847
• Product Code: MIH
• UDI-Device Identifier: 00733132610761
• UDI-Public: 00733132610761
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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: 03/31/2014
• Device Model Number: RMT311417
• Device Catalogue Number: RMT311417
• Device Lot Number: 9016838
• 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: 06/25/2020
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88