BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1031681 · Received April 18, 2008

    Report

    Report Number
    2024168-2008-00311
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Report Date
    March 21, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE DEVICE WOULD NOT CROSS THE TORTUOUS LESION, THROUGH A PREVIOUSLY IMPLANTED STENT. THERE WAS RESISTANCE FELT UPON REMOVAL AND THE STENT DISLODGED IN THE GUIDING CATHETER. NO PT EFFECTS WERE REPORTED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8012531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK