BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1800142 · Received August 10, 2010

    Report

    Report Number
    2024168-2010-01637
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED PRODUCT NOTED THE STENT HAD DISLODGED FROM THE BALLOON AND WAS RETURNED PARTIALLY INSIDE THE PROTECTIVE SHEATH, CONFIRMING THE REPORTED INFO. THERE WAS NO DAMAGE NOTED TO THE STENT. CRIMP MARKS WERE VISIBLE ON THE LOOSELY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MFR. THE PROXIMAL END OF THE PROTECTIVE SHEATH WAS OVAL SHAPED, WHICH COULD BE A RESULT OF HANDLING DURING REMOVAL. THE STENT OUTER DIAMETERS AND PROTECTIVE SHEATH INNER DIAMETER WERE MEASURED AND MET MFG CRITERIA. STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO: IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, AND HANDLING OF THE STENT DURING PREPARATION. TO ENSURE THIS IS NOT THE RESULT OF A MFG DEFICIENCY, ALL STENT DELIVERY SYSTEMS (SDS) ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. IT WAS REPORTED THE STENT DISLODGEMENT WAS NOT NOTED UNTIL THE SDS WAS ADVANCED TO THE LESION AND THE BALLOON INFLATED. IT SHOULD BE NOTED IN THE VISION INSTRUCTIONS FOR USE (IFU) IT STATES: "PRIOR TO USING THIS DEVICE, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECTED FOR BENDS, KINKS, AND OTHER DAMAGE. AFTER REMOVING THE MANDREL, REMOVE THE PROTECTIVE SHEATH CAREFULLY WHILE HOLDING ITS DISTAL END. 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 MFG RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEVICE ISSUE: DISLODGED STENT. TIME OF DEVICE ISSUE: DURING DEVICE PREPARATION. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE VISION STENT, UPON REMOVAL OF THE PROTECTIVE SHEATH, DISLODGED FROM THE BALLOON AND REMAINED IN THE SHEATH. HOWEVER, IT WAS NOT KNOWN THAT THE STENT DISLODGED, AND THE STENT DELIVERY SYSTEM WAS TAKEN TO THE LESION, THE BALLOON INFLATED AND THEN, UNDER INTRAVENOUS ULTRASOUND (IVUS), IT WAS NOTICED THAT THE STENT WAS NOT DELIVERED TO THE LESION. AT THIS POINT, THE DISLODGED STENT WAS FOUND IN THE SHEATH. THERE WAS NO ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO 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 9082741

    Patients

    Seq Age Sex Outcome Treatment
    1