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

Model Number	RLT261418
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	02/13/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #plc141400/ serial # (b)(4)/ udi # (b)(4).Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable concomitant medical products and therapy dates: asked but unavailable.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, endoleak, aneurysm rupture and death.
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On post-op follow-up on an unknown date, an unconfirmed endoleak (suspected to be a proximal type i) was observed.On 8-month post-op follow-up on an unknown date, no endoleak was present on imaging.The physician reported that the suspected endoleak was expected to have, "cleared up".The patient was lost to follow-up.On (b)(6) 2021, the patient was in a car accident and was found to be deceased.Upon autopsy it was observed that the patient's abdominal aortic aneurysm was ruptured.It is reportedly unknown if the rupture was secondary to the car accident, or if the car accident was secondary to the rupture.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11396378
• Report Number: 3007284313-2021-01273
• Device Sequence Number: 1283529
• Product Code: MIH
• UDI-Device Identifier: 00733132622474
• UDI-Public: 00733132622474
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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: 11/01/2021
• Device Model Number: RLT261418
• Device Catalogue Number: RLT261418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/01/2021
• 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: Death
• Patient Age: 74 YR