BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® MOLDING & OCCLUSION BALLOON CATHETER

    MDR report key: 17836293 · Received September 28, 2023

    Report

    Report Number
    3007284313-2023-02777
    Event Type
    Death
    Date Received
    September 28, 2023
    Date of Event
    September 22, 2023
    Report Date
    September 28, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DQY
    UDI-DI
    00733132639489
    PMA / PMN Number
    K172567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B7: PATIENT MEDICAL HISTORY INCLUDES BUT IS NOT LIMITED TO: PAD; ILIAC ARTERY PSEUDO ANEURYSM; OSTEO MYELITIS R FOOT ; AAA ; HYPERTENSION. D10: PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: TOPROL 50MG Q DAY; PLAVIX 75M Q DAY. THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE® MOLDING AND OCCLUSION BALLOON CATHETER WARNS: SEE RECOMMENDED INFLATION VOLUMES OUTLINED IN TABLE 1. DO NOT INFLATE ABOVE RECOMMENDED INFLATION VOLUMES. EXCESSIVE INFLATION VOLUME MAY RESULT IN BALLOON RUPTURE, EMBOLIZATION, VESSEL DAMAGE, VESSEL RUPTURE, OR PATIENT DEATH. DO NOT EXCEED 37 MM BALLOON DIAMETER, BALLOON RUPTURE MAY OCCUR. DO NOT EXCEED 48 CC INFLATION VOLUME AT 37 MM CONSTRAINED BALLOON DIAMETER. BALLOON OVER-INFLATION MAY RESULT IN VESSEL DAMAGE OR RUPTURE. 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.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE APPROXIMATELY 20 YEARS AGO THIS PATIENT UNDERWENT AN OPEN AORTIC BIFURCATED REPAIR OF THE ABDOMINAL AORTA. ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A LEAK (UNKNOWN TYPE) AT THE ANASTOMOSIS SITE. THE TREATMENT PLAN WAS TO PLACE 2 AORTIC EXTENSIONS ACROSS THE ANASTOMOSIS TO GAIN SEAL. THE FIRST GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED AT THE LEVEL OF THE BIFURCATION AND A SECOND GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED AT THE LEVEL OF THE RENAL ARTERY WITH SIGNIFICANT OVERLAP. BOTH GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESES DEPLOYED PROPERLY AND SUCCESSFULLY. UPON BALLOONING WITH GORE® MOLDING & OCCLUSION BALLOON CATHETER (MOB) THE PATIENT EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE. SUBSEQUENTLY AN AORTIC RUPTURE/LEAK WAS IDENTIFIED AND THE MOB WAS RELOCATED ABOVE THE LEVEL OF THE RENAL ARTERIES IN AN ATTEMPT TO STABILIZE THE PATIENT AND BLOOD FLOW. TWO ADDITIONAL GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESES WERE SUCCESSFULLY IMPLANTED AT THE RUPTURE SITE WITHOUT RESOLUTION. THE PHYSICIAN THEN DECIDED TO IMPLANT A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, WHICH WAS SUCCESSFULLY DEPLOYED, BUT DID NOT RESOLVE THE SITUATION. ALL ENDOVASCULAR ATTEMPTS TO STABILIZE THE PATIENT FAILED AND THE PATIENT CODED ON THE TABLE. CHEST COMPRESSIONS WERE PERFORMED HOWEVER THE PATIENT EXPIRED ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087230 GORE® MOLDING & OCCLUSION BALLOON CATHETER CATHETER, PERCUTANEOUS DQY W. L. GORE & ASSOCIATES, INC. 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Hospitalization| L| D