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

Catalog Number	PLL161407
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® conformable aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to: embolization (micro and macro) with transient or permanent ischemia as it is unknown which device is directly implicated in this event, the following devices (same device family) will also be included in this report: catalog #plc141000/ serial #(b)(6)/ udi #(b)(4).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
On (b)(6) 2025, the patient underwent an endovascular procedure to treat an aneurysm utilizing the gore® excluder® conformable aaa endoprosthesis and the gore® excluder® aaa endoprostheses in zone 9.The procedure was uneventful with successful exclusion of aaa.The aneurysm was sealed.The patient tolerated the procedure.It was reported that on post operation day 1, the patient was found to have no right lower extremity pulse post evar approximately 1 to 2 hours in recovery.A dry seal hydro flex sheath was used on right side.Physician theorized that possible manual compression to assist hemostasis during closure device deployment in conjunction with protamine usage caused fresh clot to form and eventual embolization.The patient was taken back to the or for a subsequent immediate or open groin exploration with clot removal.A thrombotic agent was infused to facilitate distal tibial vessel clot breakdown as well as device thrombectomy usage planned post operation day 1.The hospital did not have the necessary equipment to fully assess the patient's condition, therefore, the patient was transferred to another hospital.It was noted the patient has had diminished pulses in his feet.They plan to reintervene on (b)(6) 2025.The physician is not attributing the clot to any gore devices.The patient underwent a reintervention on (b)(6) 2025 at another hospital to removal the clot(s).The patient tolerated the procedure.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21566101
• Report Number: 3013164176-2025-02424
• Device Sequence Number: 4375317
• Product Code: MIH
• UDI-Device Identifier: 00733132618767
• UDI-Public: (01)00733132618767(17)270417
• 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
• Report Date (Section B): 03/10/2025

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: PLL161407
• 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: 02/13/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2024
• 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