BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1861109 · Received October 4, 2010

    Report

    Report Number
    2024168-2010-02060
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIRST RX VISION 3.50 X 15 MM (PART# 1007843-15/LOT #0040841) IS BEING FILED UNDER A SEPARATE MFR REPORT NUMBER. EVAL SUMMARY: POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR, POSITIVE PRESSURE DURING PREPARATION OF THE STENT DELIVERY SYSTEM (SDS), NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREP. RETURN OF THE VISION SDS MAY HAVE AIDED IN THE EVALUATION AND DETERMINATION OF CAUSE. IT IS POSSIBLE THE STENT WAS INADVERTENTLY HANDLED DURING REMOVAL OF THE PROTECTIVE SHEATH, CONTRIBUTING TO THE STENT DISLODGING; HOWEVER, THIS COULD NOT BE CONFIRMED AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKAGING OF THE DEVICE, IT WAS NOTICED THAT THE STENT WAS MISSING AND WAS NOT CRIMPED ON THE BALLOON. THE DEVICE WAS NOT USED. A SECOND RX VISION WAS USED; HOWEVER, AFTER THE INSERTION OF THE DELIVERY SYSTEM THE PHYSICIAN NOTED THAT THE STENT WAS NOT PRESENT ON THE BALLOON. THE STENT WAS FOUND TO BE IN THE PACKAGING. THE STENT DELIVERY SYSTEM WAS RETRIEVED AND ANOTHER VISION STENT WAS IMPLANTED WITH SUCCESS. NO PT EFFECTS HAVE BEEN REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT # 0040841)| RX VISION 3.50 X 15 MM (PART # 1007843-15/