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

Catalog Number	PLC121400
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, this patient underwent endovascular treatment for a zone 9 infrarenal and a common iliac artery aneurysm (ciaa) and was implanted with gore® excluder® conformable aaa endoprosthesis with active control system.The patient tolerated the procedure with great results.Final angiograpy depicted good results considering the length and tortuosity and condition of the patient¿s anatomy.The physician reports the patient had not been a good candidate for open or endovascular treatment and he had very strongly attempted to convince the patient to opt for palliative care/comfort care.Later this same day or early morning of (b)(6) 2025, the patient underwent reintervention for a kink/occlusion of the overlap zone of the two contralateral leg components located around the ciaa which was extremely tortuous.The patient additionally had a common femoral artery aneurysm (cfaa) and the superficial femoral artery (sfa) was out, clogged and occluded and diseased.The physician chose to bypass the common femoral artery (cfa) and opened the right side and performed a bypass graft directly to the profunda to eliminate the issues with the cfa.The patient tolerated the procedure and is now under palliative care.
Additional Manufacturer Narrative
Additional devices associated to this event include: plc141400/29453013, udi: (b)(4).The instructions for use (ifu) for the gore® excluder® aaa endoprostheses states; adverse events that may occur and / or require intervention include but are not limited to: endoprosthesis: occlusion, occlusion of device or native vessel.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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21439190
• Report Number: 3013164176-2025-02400
• Device Sequence Number: 4348942
• Product Code: MIH
• UDI-Device Identifier: 00733132618644
• UDI-Public: (01)00733132618644(17)271020
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PLC121400
• 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: 02/07/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2024
• 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: Required Intervention; Other; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male