BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO DRIVER OTW CORONARY STENT SYSTEM

    MDR report key: 1700861 · Received May 26, 2010

    Report

    Report Number
    2953200-2010-00933
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    April 26, 2010
    Report Date
    April 27, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ROOT CAUSE OF EVENT CANNOT BE DETERMINED BASED ON LIMITED INFO AVAILABLE.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 2.25MM DIAMETER X 14MM LENGTH MICRO DRIVER OTW (OVER THE WIRE) STENT INTO A PT. HOWEVER, IT WAS REPORTED THAT DURING ADVANCEMENT, THE RELEVANT STENT DISLODGED IN THE RCA. COMMUNICATION FROM THE FIELD CONFIRMED THAT THE DISLODGED STENT WAS SUBSEQUENTLY CRUSHED AGAINST VESSEL WALL. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRIVER OTW CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0001062958

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention