BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1800043 · Received August 12, 2010

    Report

    Report Number
    2024168-2010-01643
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 19, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS CONTRAST IN THE INFLATION LUMEN AND IN THE BALLOON. THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE BALLOON AND WAS LOCATED ON THE STYLET. THERE WERE BENT STRUTS ON THE FIRST SIX ROWS AT THE DISTAL END OF THE STENT IMPLANT. THERE WERE FLARED STRUTS ON THE FIRST ROW AT THE PROXIMAL END OF THE STENT IMPLANT. THERE WERE BENT STRUTS ON THE THIRD, FOURTH, AND FIFTH ROW AT THE PROXIMAL END OF THE STENT IMPLANT AND BENT STRUTS ON THE MIDDLE OF THE STENT IMPLANT. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE BALLOON WAS LOOSELY FOLDED. THE ORANGE PROTECTIVE SHEATH WAS RETURNED ON THE STYLET. THERE WAS NO DAMAGE NOTED TO THE STYLET OR PROTECTIVE SHEATH. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE OUTER DIAMETERS OF THE STENT IMPLANT WERE NOT MEASURED DUE TO THE DAMAGE NOTED TO THE STENT. PIN GAUGES WERE USED TO MEASURE THE INNER DIAMETER OF THE FLARED END ON ORANGE PROTECTIVE SHEATH. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO INFLATE THE BALLOON BUT THE BALLOON WOULD NOT INFLATE. AFTER THE SDS WAS PRESSURIZED AND SOAKED TO DISSOLVE THE DRIED CONTRAST IN THE INFLATION LUMEN AND IN THE BALLOON, A NEW INDEFLATOR WAS USED TO INFLATE THE BALLOON TO 16ATM (RBP) WITH NO DAMAGE NOTED. THERE WAS NO RUPTURE OR LEAK NOTED TO THE SDS. IN THIS CASE, IT IS POSSIBLE THAT THE CONTRAST MIX RATIO MAY NOT HAVE BEEN IMPROPERLY DILUTED AND COULD HAVE CONTRIBUTED TO THE INFLATION FAILURE. CONTRAST THAT IS MORE CONCENTRATED CAN LEAD TO SLOWER INFLATION. THE INSTRUCTIONS FOR USE (IFU) STATES: THE CONTRAST IS 60% CONTRAST DILUTED 1:1 WITH NORMAL SALINE. IT IS LIKELY THAT AS THE BALLOON WAS ATTEMPTED TO BE FULLY INFLATED, THE STENT PARTIALLY EXPANDED BECOMING LOOSE ON THE BALLOON; THEREFORE, DURING REMOVAL OF THE SDS, THE STENT WOULD MOVE. HANDLING OF THE STENT AFTER THE PROCEDURE DURING PACKAGING, HANDLING, AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS WOULD HAVE CONTRIBUTED TO THE STENT DISLODGING FROM THE BALLOON. IN THIS CASE, RETURN ANALYSIS OF THE PRODUCT WAS UNABLE TO CONFIRM A LEAK OR RUPTURE WITH THE SDS. ADDITIONALLY, THE DIFFICULTY INFLATING THE BALLOON AND STENT DISLODGEMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE RATED BURST PRESSURE. 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

    DEVICE ISSUE: INCOMPLETE INFLATION / LOOSE STENT. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID CIRCUMFLEX WITH SEVERE TORTUOSITY. THE 3.0 X 23 MM VISION WAS ADVANCED TO THE LESION AND PRESSURIZED, BUT THE BALLOON PARTIALLY INFLATED AND THEN LOST PRESSURE. AN ATTEMPT WAS MADE TO REMOVE THE DEVICE AND AS THE STENT DELIVERY SYSTEM (SDS) WAS WITHDRAWN, THE STENT MOVED ON THE BALLOON, BUT DID NOT DISLODGE. THE SDS WAS REMOVED AND A NEW VISION STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM MAF ABBOTT VASCULAR CLONMEL NA 9040641

    Patients

    Seq Age Sex Outcome Treatment
    1