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

Catalog Number	PLC201000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, this patient underwent endovascular treatment of an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses (rlt311413/15200324, pxc121400/15426697, pxc121000/13444897, plc201000/ (b)(6).The patient tolerated the procedure.On an unknown date in (b)(6) 2024, the patient was evaluated for type ii endoleak, however, the patient did not return for any follow-ups.On an unknown date in (b)(6) 2024, the patient underwent embolization for a type ii endoleak.The procedure was not supported by a gore associate.On (b)(6) 2024, the patient presented with a proximal type i endoleak with aneurysm enlargement (amount unknown) coupled with a rupturing abdominal aortic aneurysm into the retroperitoneum.The patient underwent surgical conversion and the trunk ipsilateral component and portions of the contralateral limbs in the distal aorta were cut off and explanted.A surgical graft was then placed and sewed to the distal portions of the grafts left in place.The patient tolerated the procedure with good results.This procedure was not supported by a gore associate.
Additional Manufacturer Narrative
The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak, conversion w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20327844
• Report Number: 3007284313-2024-03500
• Device Sequence Number: 20834331
• Product Code: MIH
• UDI-Device Identifier: 00733132618590
• UDI-Public: 00733132618590
• 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: 2017
• Device Explanted Year: 2024
• 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): 09/27/2024

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
• Device Expiration Date: 03/29/2018
• Device Catalogue Number: PLC201000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/27/2024
• Date Device Manufactured: 03/30/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 77 KG