BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1864953 · Received October 6, 2010

    Report

    Report Number
    2024168-2010-02088
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIC LESION IN THE 1ST OBTUSE MARGINAL. THE 2.25 X 28 MINI VISION WAS ADVANCED, BUT COULD NOT NEGOTIATE THE LESION SITE BECAUSE OF THE HEAVY TORTUOSITY. A 1.5 X 15 RX VOYAGER WAS USED FOR ADDITIONAL PRE-DILATATION AND ANOTHER ATTEMPT WAS MADE TO ADVANCE THE MINI VISION. THE STENT DELIVERY SYSTEM (SDS) WAS PUSHED A LITTLE HARDER INTO THE CIRCUMFLEX, BUT THE PROXIMAL END OF THE SDS KINKED SEVERAL TIMES AND THEN SEPARATED. THE DEVICE WAS REMOVED AND THERE WERE NO REPORTED PT EFFECTS. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME SIZE MINI VISION AFTER PRE-DILATING THE LESION WITH A NON-ABBOTT BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 9030941

    Patients

    Seq Age Sex Outcome Treatment
    1 SPRINTER 2.0 X 10 BALLOON| DIL CATH: 1.5 X 15 RX VOYAGER