BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK VISION CORONARY STENT SYSTEM

    MDR report key: 1081489 · Received July 23, 2008

    Report

    Report Number
    2024168-2008-00597
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 21, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIRST TWO UNK VISION STENTS WERE FILED UNDER MFR #2024168-2008-00584. RESULTS AND CONCLUSION SUMMATION - IT SHOULD BE NOTED THAT AS PER THE INSTRUCTIONS FOR USE (IFU), THE USE OF THIS DEVICE IS CONTRAINDICATED FOR "PATIENTS IN WHOM ANTI-PLATELET AND/OR ANTICOAGULANT THERAPY IS CONTRAINDICATED".

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/SURGICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: THROMBOSIS REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT AFTER TWO VISION STENTS WERE IMPLANTED, THE PT DEVELOPED IN-STENT THROMBOSIS WITHIN 4-6 DAYS AND WAS TREATED WITH A THIRD VISION STENT WHICH ALSO DEVELOPED IN-STENT THROMBOSIS WITHIN 4-6 DAYS. THE PT WAS THEN SENT TO SURGERY WHERE A CORONARY ARTERY BYPASS GRAFT (CABG) WAS PERFORMED. REPORTEDLY, THE PT IS UNABLE TO TAKE PLAVIX OR WAS NOT FOLLOWING THE PROTOCOL ON TAKING PLAVIX. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R| S SYSTEM (PART#'S UNK| STENT: (2) MULTI-LINK RX VISION CORONARY STENT