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

Catalog Number	PLC141200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Ischemia (1942); Respiratory Failure (2484); Embolism/Embolus (4438); Renal Impairment (4499)
Date of Event	04/21/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #plc141000/ serial #(b)(6)/ udi #(b)(4) as a component of the same system.Catalog #ataa43720160a/ serial #(b)(6)/ udi #(b)(4) which is captured in manufacturer report #2017233-2025-06209.Catalog #ceb231410a/ serial #(b)(6)/ udi #(b)(4) which is captured in manufacturer report #3013164176-2025-02530.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 through the aaa 24-01 tambe post approval study: on (b)(6) 2025, the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) device system.An ataa43720160a tambe aortic component, ceb231410a gore® excluder® iliac branch endoprosthesis iliac branch component, and two gore® excluder® aaa endoprosthesis contralateral leg components (plc141000 and plc141200) were implanted.A csf drain and intraoperative neurophysiological monitoring (mep/ssep) were utilized prophylactically during the procedure.On the same day, cholesterol emboli syndrome, acute kidney injury (aki), and right lower extremity ischemia were reported.The cholesterol emboli syndrome was noted as disease related.The aki was noted as not related to the device, procedure, or disease.The patient was taken back to the operating room for right common femoral artery thromboendarterectomy, right femoral artery interposition graft placement, and thrombectomy of the right femoropopliteal artery.The ischemia was noted as resolved on the same day.On (b)(6) 2025, the patient entered respiratory failure.It was noted that the respiratory failure required prolonged (>24 hour) mechanical ventilation or reintubation.The respiratory failure was noted as not related to the device, procedure, or disease.The patient was placed on continuous renal replacement therapy (new onset dialysis) for treatment of the aki on (b)(6) 2025.On (b)(6) 2025, the patient expired.The cause of death was noted as related to the respiratory failure and cholesterol emboli syndrome.
Additional Manufacturer Narrative
H.6.Investigation conclusions codes d1001 and d12 remain unchanged.Additional manufacturer narrative: ifu statement corrected.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related 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, renal complications (e.G., artery occlusion, contrast toxicity, insufficiency, failure), pulmonary complications (e.G., pneumonia, respiratory failure), and death.Additionally, the ifu states that key anatomic elements that may affect successful exclusion of the aneurysm include, but are not limited to, significant thrombus and/or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22926036
• Report Number: 3013164176-2025-02657
• Device Sequence Number: 10230836
• Product Code: MIH
• UDI-Device Identifier: 00733132618675
• UDI-Public: (01)00733132618675(17)271202
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: PLC141200
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DIRECT ORAL ANTICOAGULANT (UNK).
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention; Death
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White