BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 9696526 · Received February 11, 2020

    Report

    Report Number
    3007284313-2020-00044
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    January 17, 2020
    Report Date
    February 12, 2020
    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 · 0

    H.6. CODE 213: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® MOLDING & OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS WHICH MAY REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO TRAUMA TO THE VESSEL WALL, INCLUDING SPASM, DISSECTION, PERFORATION OR RUPTURE. DO NOT EXCEED 48 CC INFLATION VOLUME AT 37 MM CONSTRAINED BALLOON DIAMETER. BALLOON OVER-INFLATION MAY RESULT IN VESSEL DAMAGE OR RUPTURE. EXCESSIVE INFLATION VOLUME MAY RESULT IN BALLOON RUPTURE, EMBOLIZATION, VESSEL DAMAGE, VESSEL RUPTURE, OR PATIENT DEATH. DO NOT USE THE GORE® MOLDING AND OCCLUSION BALLOON CATHETER FOR MORE THAN 20 INFLATION / DEFLATION CYCLES. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ALSO, A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM (RLT231216J/ 20886367) WAS INVOLVED. PLEASE NOTE THAT THE MEDWATCH#3007284313-2020-00043 WAS EMAILED TO FDA ON FEBRUARY 11, 2020. 510(K) NUMBER: K172567.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER STENT GRAFTS WERE PLACED AS PLANNED, TOUCH UP BALLOONING WAS PERFORMED USING A GORE® MOLDING & OCCLUSION BALLOON CATHETER. PROCEDURAL ANGIOGRAPHY REVEALED LOCALIZED DISSECTION AT THE PROXIMAL EDGE OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH AND NO FURTHER TREATMENT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN IS MONITORING THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THAT THE BALLOON WAS POSSIBLY OVER INFLATED AND IT RESULTED IN THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156402 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES MOB37 21162689 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other