BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD VASCULAR

    MDR report key: 21481219 · Received February 27, 2025

    Report

    Report Number
    2124215-2025-08209
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GOOD FAITH EFFORT STATED THAT THE EVENT/PROCEDURE DATE WAS ON (B)(6) 2025. HOWEVER, THE EVENT NOTIFICATION DATE WAS RECEIVED ON FEBRUARY 03, 2025, CST. USED FEBRUARY 03, 2025, AS THE AWARE DATE AND EVENT DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED, REQUIRING INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH USING A 7FR SHEATH. THE 50% TIGHT STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0X60X135 CM EXPRESS LD VASCULAR STENT BALLOON EXPANDABLE WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT DISLODGED FROM THE CATHETER IN THE RIGHT ILIAC WITHOUT INFLATING THE DEVICE. THE STENT WAS TAKEN OUT BY USING A 3X60 MUSTANG BALLOON FROM THE BODY WITH ADDITIONAL INCISION NEARBY THE SHEATH. THE PROCEDURE WAS COMPLETED WITH PLAIN OLD BALLOON ANGIOPLASTY USING A MUSTANG CATHETER, AND IT WAS ENSURED THAT THERE WAS NO BLEEDING, AND THAT BLOOD FLOW WAS RESTORED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960779 EXPRESS LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION 20212 0031996134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention