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

Catalog Number	PLC161400
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c21 - results pending determination and completion of investigations.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.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2024, the patient underwent endovascular repair of a zone 9 infrarenal abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis (trunk-ipsilateral leg), with deployment of a gore® excluder® aaa endoprosthesis contralateral leg component on the contralateral side.On (b)(6) 2026, reintervention was required due to compression of the left contralateral limb at the level of the flow divider of the previously implanted gore® excluder® conformable aaa endoprosthesis.The compression involved the primary (proximal), gate-seated contralateral leg, with no compression of the trunk component.The compression was attributed to patient-specific anatomy/pathology immediately distal to the flow divider, rather than a device-related mechanical issue such as graft infolding or kinking.Limb compression was initially detected on ct imaging, which demonstrated a slight narrowing of the affected segment.Although clinical symptoms were not reported prior to reintervention, the physician elected to perform angiography to further assess the focal area and determine the appropriate treatment modality.During the reintervention, a gore® viabahn® vbx balloon expandable endoprosthesis was deployed within the proximal portion of the contralateral limb to reline the affected segment.The procedure was completed successfully, and the patient tolerated the intervention well.Code 6000-c: -anatomy for treatment - other/unknown used to capture an anatomy/pathology-related cause of unspecified etiology.
Additional Manufacturer Narrative
Updated g3/g4, h2/h3/h6/h11.H6: code b20 ¿ the device remains implanted and, therefore, was not available for direct analysis by gore.H6: code c19 ¿ a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: brittany pettengill ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24713146
• Report Number: 3013164176-2026-02947
• Device Sequence Number: 5763031
• Product Code: MIH
• UDI-Device Identifier: 00733132618729
• UDI-Public: (01)00733132618729(17)270110
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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 Catalogue Number: PLC161400
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male