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

Model Number	RMT311415
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/08/2020
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.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, aneurysm enlargement, and surgical conversion.Please note: this lot# was previously investigated in mfr report numbers 2017233-2017-00148, 2017233-2018-00593.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2013, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 80 mm in diameter and was treated with gore® excluder® aaa endoprostheses.On (b)(6) 2018, follow-up computed tomography angiography imaging revealed an aneurysm diameter of 102 mm.On (b)(6) 2019, a follow-up office visit on the patient was performed without imaging.On (b)(6) 2020, follow-up ultrasound examination showed an aneurysm diameter of 106 mm due to a reportedly known type ii endoleak first identified on (b)(6) 2013.On (b)(6) 2020, the patient was converted to open surgery during which all gore® excluder® endoprostheses were reportedly explanted.

• 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: 10141374
• Report Number: 2017233-2020-00429
• Device Sequence Number: 3300378
• Product Code: MIH
• UDI-Device Identifier: 00733132610754
• UDI-Public: 00733132610754
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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: 10/31/2014
• Device Model Number: RMT311415
• Device Catalogue Number: RMT311415
• Device Lot Number: 9752354
• 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: 06/10/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 103