BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS¿ .035" OTW PTA DILATATION CATHETER

    MDR report key: 2928345 · Received January 24, 2013

    Report

    Report Number
    2183870-2013-00025
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    September 11, 2012
    Report Date
    January 15, 2013
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS UNAVAILABLE.

    Description of Event or Problem · 1

    A COMPLEX INTERVENTION WAS PERFORMED ON A 100% CHRONICALLY OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY WITH AN EVERCROSS. THERE WAS A REPORTED DISSECTION OF THE LEFT MID SFA DURING RECANALIZATION OF THE 100% OCCLUDED SFA AFTER PTA WITH THE EVERCROSS. THE PHYSICIAN THEN PLACED A SELF-EXPANDING STENT DISTALLY AND COVERED IT WITH A 7X80 STENT PROXIMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34325 EVERCROSS¿ .035" OTW PTA DILATATION CATHETER CATHETER, PERCUTANEOUS DQY EV3 INC. AB35W05150135 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 6X200 PROTEGE EVERFLEX STENT| 2.0 CSI| 7X80 PROTEGE EVERFLEX STENT