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

Catalog Number	PLC231400
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	08/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unclear which, if any, of the gore® excluder® aaa endoprosthesis contralateral leg devices caused or contributed to this event.Additional excluder® included on this report sn: (b)(6), udi: (b)(4), catalog: plc141200, sn: (b)(6), udi: (b)(4), catalog: plc201400.H.6.Type of investigation code b20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation conclusions code d15: there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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 have not 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 was reported to gore on august 19, 2025 from the imedidata study database: on (b)(6) 2025, this 78-year-old male patient underwent endovascular treatment.The patient was treated with a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) aortic component.The gore® device was successfully navigated to the intended location and successfully deployed.On (b)(6) 2025, the patient was noted to have a stroke.This adverse event is noted as ongoing (not recovered/not resolved).Reportedly, the event is not related to the device, procedure or disease, and was not potentially caused by a gore accessory.
Additional Manufacturer Narrative
B3/b4/b5/b6: event description updated.H6: investigation conclusions: updated code to d14.This report serves as a correction to a previously submitted report that identified a patient event as a "stroke." upon further clinical review, the event has been clarified to be an intra-cranial hemorrhage.There is no known or suspected causal relationship between this event and any w.L.Gore medical device.Based on this updated information, the previously submitted report is being formally retracted.
Event or Problem Description
Upon further clinical review, the event previously reported as a stroke has been clarified as an intra-cranial hemorrhage.

• 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: 23083860
• Report Number: 3013164176-2025-02682
• Device Sequence Number: 14613725
• Product Code: MIH
• UDI-Device Identifier: 00733132618583
• UDI-Public: (01)00733132618583(17)280304
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 11/14/2025

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
• Device Catalogue Number: PLC231400
• Device Lot Number: 30275210
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White