BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® MOLDING & OCCLUSION BALLOON CATHETER

    MDR report key: 22520178 · Received July 16, 2025

    Report

    Report Number
    3007284313-2025-04112
    Event Type
    Death
    Date Received
    July 16, 2025
    Date of Event
    June 19, 2025
    Report Date
    August 20, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DQY
    PMA / PMN Number
    K172567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    ADDED G3/G4, H1/H2, H6. ACCORDING TO THE GORE® MOLDING & OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE TRAUMA TO THE VESSEL WALL, INCLUDING RUPTURE.

    Description of Event or Problem · 0

    THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM - RUPTURE UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT THE ANEURYSM WAS EMERGENT, IT HAD NOT YET RUPTURED HOWEVER, IT WAS EXTREMELY ENLARGED. IT WAS OVER 10CM. AFTER IMPLANTATION OF THE TRUNK IPSILATERAL COMPONENT, AN AORTIC OCCLUSION BALLOON WAS USED TO DILATE THE MAIN BODY PORTION OF THE DEVICE. AFTER THE BALLOON WAS DEFLATED, THE PATIENTS PRESSURE MARKEDLY DROPPED. AN ANGIOGRAM WAS PERFORMED WHICH SHOWED A LARGE AMOUNT OF EXTRALUMINAL CONTRAST ORIGINATING FROM THE DISTAL AORTA NECK. AORTIC EXTENDERS WERE DEPLOYED PROXIMALLY TO TRY AND SEAL THE LARGE TYPE 1A ENDOLEAK WHICH WAS PRESENT DUE TO CALCIUM IN THE PROXIMAL NECK. THE PATIENT WAS NOT A CANDIDATE FOR CONVERSION TO OPEN REPAIR SO COMFORT CARE WAS CHOSEN, AND THE PATIENT EXPIRED A COUPLE HOURS AFTER THE PROCEDURE. THE PHYSICIAN BELIEVES THAT CAUSE OF THE REPORTED EVENT WAS DUE TO THE DISTAL AORTIC NECK RUPTURE DURING BALLOON DILATION OF THE PROXIMAL INFRARENAL AORTIC NECK, CALCIUM PRESENT IN THE PROXIMAL SEALING ZONE, AND A LARGE 1A ENDOLEAK THAT COULDN'T BE RESOLVED THAT LED TO EXSANGUINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161933 GORE® MOLDING & OCCLUSION BALLOON CATHETER CATHETER, PERCUTANEOUS DQY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death MEDICATION - INHALERS