BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1082073 · Received July 23, 2008

    Report

    Report Number
    2024168-2008-00591
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 23, 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
    CA
    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 VISION STENT DELIVERY SYSTEM (SDS) WAS INSERTED IN PT AND IT WAS NOTICED ON X-RAY THAT THERE WAS NO STENT. IT WAS LATER FOUND IN THE PT'S DRAPE. A NEW 3.5 X 15MM STENT WAS USED SUCCESSFULLY. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8042131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK