BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 9667170 · Received February 4, 2020

    Report

    Report Number
    3007284313-2020-00031
    Event Type
    Injury
    Date Received
    February 4, 2020
    Date of Event
    January 8, 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.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION IS IN PROCESS. FURTHER INFORMATION WILL BE PROVIDED. ALSO, A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC231000J/ 20685473) WAS INVOLVED. PLEASE NOTE THAT THE MEDWATCH# 3013164176-2020-00012 WAS EMAILED TO FDA ON FEBRUARY 4, 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. WHEN THE TOUCH UP BALLOONING WAS PERFORMED BY A GORE® MOLDING & OCCLUSION BALLOON (MOB) TO A STENT GRAFT IMPLANTED IN THE LEFT COMMON ILIAC ARTERY, THE BLOOD PRESSURE BECAME DECREASED. IT WAS CONFIRMED THAT THE LEFT COMMON ILIAC ARTERY WAS RUPTURED. THE BLOOD PRESSURE BECAME STABLE AFTER OCCLUDING THE PROXIMAL PART OF THE STENT GRAFT USING THE BALLOON. THEN THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND AN ADDITIONAL STENT GRAFT WAS EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERANT THE PROCEDURE. REPORTEDLY, THE BALLOON WAS NOT OVER INFLATED. NO RESISTANCE WAS FELT DURING ADVANCEMENT OR RETRACTION OF THE BALLOON CATHETER. THE VESSEL¿S SIZE AT THE BALLOONING AREA WAS 19MM. THERE WAS NOTHING IN PATIENT¿S ANATOMY CAUSED OR CONTRIBUTED TO THE EVENT. THE PHYSICIAN COMMENTED: ANOTHER MANUFACTURER¿S BALLOON EXPANDS PROXIMALLY AND DISTALLY DURING BALLOONING. HOWEVER, MOB DOESN¿T. THEREFORE, PRESSURE OF MOB TRANSMITTED TO VESSEL DIRECTLY WHICH RESULTED THE LEFT COMMON ILIAC ARTERY RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128123 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES MOB37 21298133 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R