BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1122285 · Received August 13, 2008

    Report

    Report Number
    2024168-2008-00659
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 14, 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
    KS, 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 RX VISION STENT IMPLANT DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) WHEN THE PROTECTIVE SHEATH WAS REMOVED. REPORTEDLY, THERE WAS NO PT INVOLVEMENT WITH THIS DEVICE. 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 7121831

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR