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

Catalog Number	PLC141000
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Device Stenosis (4066)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, a patient was treated for an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.On (b)(6) 2025, a follow-up ct was taken showing compression on the left contralateral limb, distal to the gate, near the distal bifurcation.On (b)(6) 2025, the physician contacted a gore rep about performing a reintervention.On (b)(6) 2025, the physician implanted two gore® viabahn® vbx balloon expandable endoprostheses.Reportedly, there was good result with improved flow to both limbs.The physician is unsure about the cause of the compression, but the aorta was a normal diameter.
Additional Manufacturer Narrative
It is unclear which device was compressed.Additional gore® excluder® device captured on this report: sn: (b)(6), udi: (b)(4), catalog: plc141200.H.6.Investigation findings code c21: investigation findings waiting on results of imaging evaluation.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.
Additional Manufacturer Narrative
H.6.Investigation conclusions code d14: based on the imaging evaluation, the compression was confirmed to have occurred on the plc141200, not the plc141000.Since there is no allegation of deficiency against the primary device on this report, it is being retracted.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21624847
• Report Number: 3013164176-2025-02440
• Device Sequence Number: 8510335
• Product Code: MIH
• UDI-Device Identifier: 00733132618637
• UDI-Public: (01)00733132618637(17)270827
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/27/2025

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?: Yes
• Device Catalogue Number: PLC141000
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male