BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRASTENT DOUBLESTRUT PARAMOUNT

    MDR report key: 528648 · Received February 25, 2004

    Report

    Report Number
    2134479-2004-00001
    Event Type
    Malfunction
    Date Received
    February 25, 2004
    Date of Event
    January 15, 2004
    Report Date
    February 23, 2004
    Manufacturer
    EV3 INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STENT CAME OFF THE BALLOON. THE PHYSICIAN RETRIEVED THE STENT AND DETERMINED IT WAS SAFE TO DEPLOY IN THE VENA CAVA. THE PHYSICIAN THEN COMPLETED THE PROCEDURE WITH A GENESIS STENT. ADDITIONAL INFO WAS RECEIVED IN 02/04: THE PHYSICIAN WAS ABLE TO PLACE A LOW PROFILE BALLOON THROUGH THE STENT THOUGH COULD NOT RECOVER THE STENT THROUGH THE SHEATH IN THE FEMORAL VEIN. THE PHYSICIAN DECIDED NOT TO UP SIZE THE SHEATH, SO THE DECISION WAS MADE TO PLACE THE STENT IN THE DISTAL VENA CAVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY CATHETER FGE EV3 INC SPM16-16-07-B 243234

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GENESIS STENT