BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1812141 · Received August 17, 2010

    Report

    Report Number
    2953200-2010-01567
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: (ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 3.0MM DIAMETER X 24MM LENGTH DRIVER RAPID EXCHANGE (RX) CORONARY STENT INTO A PT; HOWEVER, IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, NO STENT COULD BE SEEN ON THE BALLOON OF RELEVANT DEVICE. THE PT IS REPORTED TO BE FINE AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0001150949

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK