BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM

    MDR report key: 1890293 · Received October 22, 2010

    Report

    Report Number
    2024168-2010-02235
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED MULTI-LINK MINI VISION STENT DELIVERY SYSTEM (SDS) NOTED DRIED CONTRAST ON THE SHAFT, BALLOON, AND IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH HANDLING AND PREPARATION. THE STENT WAS DISLODGED FROM THE BALLOON AND RETURNED ON THE STYLET PROXIMAL TO THE PROTECTIVE SHEATH. THERE WAS NO DAMAGE NOTED TO THE STENT. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THERE WAS A KINK IN THE SHAFT 62 CM DISTAL TO THE STRAIN RELIEF TUBING. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINK MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT. 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 MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE SDS< NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. THE STENT OUTER DIAMETERS AND INNER DIAMETER OF THE PROTECTIVE SHEATH WERE MEASURED AND MET MANUFACTURING CRITERIA. IT WAS REPORTED THE STENT DISLODGEMENT WAS NOT NOTED UNTIL THE SDS WAS ALREADY ADVANCED INTO THE PATIENT ANATOMY. IT SHOULD BE NOTED IN THE MINI VISION INSTRUCTIONS FOR USE (IFU) IT STATES: "PRIOR TO USING THE MULTI-LINK MINI VISION CSS, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED." A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT DISLODGED IN THE SHEATH PRIOR TO USE; HOWEVER, IT WAS NOT NOTICED UNTIL THE DEVICE WAS PLACED IN THE LESION AND WAS READY FOR DEPLOYMENT. THERE WERE NO PATIENT EFFECTS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SOME SIZE DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM MAF ABBOTT VASCULAR - CARDIAC THERAPIES NA 0042641

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK