BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 883420 · Received July 20, 2007

    Report

    Report Number
    2024168-2007-00283
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 13, 2007
    Report Date
    July 13, 2007
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    2024168-07/13/-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING HAS NOT COMPLETED THEIR REVIEW OF THE EVENT AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED TO NOTIFY THE FDA'S OFFICE OF SURVEILLANCE (OSB) BRANCH OF THE 806 REPORTABLE ACTION TAKEN. ON JULY 13, 2007, ABBOTT VASCULAR CARDIAC THERAPIES INITIATED A RECALL ON A SINGLE LOT (43 UNITS) OF MULTI-LINK RX VISION CORONARY STENT SYSTEMS, PART NUMBER 1007848-15, LOT NUMBER 7052951. THE RECALL WAS INITIATED BECAUSE THE PRODUCT LOT DESCRIBED ABOVE WAS INADVERTENTLY RELEASED NOT MEETING INTERNAL PERFORMANCE SPECIFICATIONS FOR STENT SECURITY, WHICH COULD RESULT IN STENT DISLODGEMENT DURING USE. ALTHOUGH THERE HAVE BEEN NO COMPLAINTS REPORTED FOR THIS PART/LOT NUMBER ASSOCIATED WITH THIS RECALL, STENT DISLODGEMENT HAS BEEN KNOWN TO CAUSE SERIOUS INJURY AND/OR REQUIRED MEDICAL INTERVENTION. A FOLLOW-UP SUPPLEMENTAL REPORT WILL BE FILED ONCE ADDITIONAL INFORMATION, INCLUDING INVESTIGATION RESULTS, AND ANY ASSOCIATED PLANNED CORRECTIVE ACTIONS ARE, RECEIVED.

    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 7052951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR