BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS WALLSTENT

    MDR report key: 15521029 · Received September 30, 2022

    Report

    Report Number
    2124215-2022-38470
    Event Type
    Injury
    Date Received
    September 30, 2022
    Date of Event
    September 9, 2022
    Report Date
    September 30, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QKJ
    UDI-DI
    08714729979609
    PMA / PMN Number
    P980033/S050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALLOON BURST AND A FRAGMENT BECAME ENTRAPPED ON THE IMPLANTED STENTS. THE TARGET LESION WAS 65% STENOSED AND LOCATED IN THE ILIAC VEIN. TWO VENOUS WALLSTENTS WERE SUCCESSFULLY IMPLANTED TO TREAT MAY-THURNER SYNDROME. AN XXL BALLOON WAS SELECTED FOR USE TO POST-DILATE THE VENOUS WALLSTENTS. THE XXL BALLOON WAS INFLATED TWICE AT FIVE ATMOSPHERES FOR 30 SECOND DURATIONS. HOWEVER, THE BALLOON BURST AND A FRAGMENT BECAME CAUGHT ON THE IMPLANTED WALLSTENTS. THE PHYSICIAN ATTEMPTED TO USE A SNARE TO REMOVE THE FRAGMENT BUT WAS UNSUCCESSFUL. ANOTHER STENT WAS THEN IMPLANTED TO TRAP THE BALLOON FRAGMENT AGAINST THE IMPLANTED STENTS. A FUTURE PROCEDURE IS PLANNED IN ORDER TO REMOVE THE BALLOON FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648233 VENOUS WALLSTENT STENT, ILIAC VEIN QKJ BOSTON SCIENTIFIC CORPORATION H74912044186070 0028269879 08714729979609

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other