BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1040156 · Received May 9, 2008

    Report

    Report Number
    2024168-2008-00390
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 11, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY / PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT REMAINS IN PT. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT TWO ATTEMPTS TO CROSS THE LESION WERE MADE WITH TWO OF ANOTHER COMPANY'S DES STENTS. AFTER BOTH ATTEMPTS, THE STENTS WERE FOUND TO BE FLARED. THE VISION WAS THEN ATTEMPTED, BUT ALSO FAILED TO CROSS THE LESION AND DISLODGED. IT IS UNK IF THE STENT WAS RETRIEVED OR IF THE STENT REMAINS IN THE PT. ANOTHER COMPANY'S 2.5 X 15 STENT DID CROSS AND WAS IMPLANTED. NO ADD'L 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 7111421

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability