BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 9183072 · Received October 12, 2019

    Report

    Report Number
    3007284313-2019-00312
    Event Type
    Injury
    Date Received
    October 12, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 1, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    UDI-DI
    00733132639489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #K172567. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® MOLDING & OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE (IFU), POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, TRAUMA TO THE VESSEL WALL, INCLUDING SPASM, DISSECTION, PERFORATION, OR RUPTURE. FURTHERMORE, THE IFU STATES WARNING: EXCESSIVE INFLATION VOLUME MAY RESULT IN BALLOON RUPTURE, EMBOLIZATION, VESSEL DAMAGE, VESSEL RUPTURE, OR PATIENT DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® MOLDING & OCCLUSION BALLOON AS AN ACCESSORY IN THE PROCEDURE. IT WAS REPORTED THAT GORE® EXCLUDER® AAA ENDOPROSTHESES WERE USED TO TREAT THE ABDOMINAL AORTIC ANEURYSM. A CONTRALATERAL LEG COMPONENT WAS SUCCESSFULLY PLACED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. TOUCH UP BALLOONING WAS PERFORMED TWICE ON THE CONTRALATERAL LEG COMPONENT USING THE GORE® MOLDING & OCCLUSION BALLOON. UPON POST DEPLOYMENT BALLOONING, THE PATIENT'S RIGHT COMMON ILIAC ARTERY WAS RUPTURED. THE PHYSICIAN NOTED THAT THE BALLOONING WAS PERFORMED WITH EXCESSIVE FORCE CAUSING THE RUPTURE. THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED. AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY, EXTENDING TO THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY TO REPAIR THE RUPTURE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977250 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 20793471 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R