BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1063832 · Received June 19, 2008

    Report

    Report Number
    2024168-2008-00500
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 20, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAD CAUSED OR CONTRIBUTED TO PATIENT INJURY, PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT WHEN THE ORANGE PROTECTIVE SHEATH AND MANDREL WERE REMOVED FROM THE STENT DELIVERY (SDS), THE STENT CAME OFF OF THE SDS BALLOON. REPORTEDLY, THERE WAS NO PATIENT INVOLVEMENT WITH THIS DEVICE. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 8040131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK