BEUDAMED
    FDA Adverse Event Death Summary report: N

    Q50 PLUS STENT GRAFT BALLOON CATHETER

    MDR report key: 6210995 · Received December 28, 2016

    Report

    Report Number
    3009766315-2016-00001
    Event Type
    Death
    Date Received
    December 28, 2016
    Date of Event
    August 16, 2016
    Report Date
    September 29, 2016
    Manufacturer
    QX MEDICAL, LLC
    Product Code
    MJN
    PMA / PMN Number
    K120381
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANALYSIS CAN BE COMPLETED SINCE THE DEVICE WILL NOT BE RETURNED AS INDICATED IN THE ASSOCIATED EVENT REPORT. ADDITIONAL REVIEW CANNOT BE CONDUCTED AS THE DEVICE LOT NUMBER WAS NOT PROVIDED. THE INFORMATION PROVIDED INDICATES THAT THE BALLOON CATHETER WAS USED TO EXPAND A 31 MM DIAMETER MODEL STENT IN A 25 MM VESSEL, USING A 60CC SYRINGE. NO INFORMATION WAS PROVIDED REGARDING THE INFLATION VOLUME USED. QXMEDICAL WILL CONTINUE TO MONITOR FOR RE-OCCURRENCES. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (31 X14.5 MODEL GORE EXCLUDER C3). IT WAS REPORTED AFTER THE TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED, TOUCH UP BALLOONING WAS PERFORMED. AFTER THE TOUCH UP BALLOONING, ANGIOGRAPHY REPORTEDLY SHOWED THE PATIENT'S AORTA HAD RUPTURED PROXIMAL TO THE TRUNK-IPSILATERAL LEG COMPONENT. IT WAS REPORTED THE BALLOON WAS COMPLETELY WITHIN THE DEVICE WHILE INFLATED. THE PATIENT REPORTEDLY UNDERWENT SURGICAL REPAIR TO TREAT THE RUPTURE. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE. ON THE SAME DAY, THE PATIENT REPORTEDLY EXPIRED POST PROCEDURE DUE TO "PROFOUND COAGULOPATHY AND ONGOING BLEEDING DESPITE GETTING THE AORTA CONTROLLED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860194 Q50 PLUS STENT GRAFT BALLOON CATHETER BALLOON CATHETER MJN QX MEDICAL, LLC 65P UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death