BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1951086 · Received January 6, 2011

    Report

    Report Number
    2024168-2011-00048
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED MULTI-LINK RX VISION STENT DELIVERY SYSTEM (SDS) NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN AND BLOOD ON THE TIGHTLY-FOLDED BALLOON, WHICH IS CONSISTENT WITH HANDLING AND SUGGESTS THAT THE SDS WAS PREPARED FOR USE. THE STENT IMPLANT WAS FOUND TO BE STATIONARY ON THE BALLOON, BUT HAD MOVED DISTALLY WHERE THE DISTAL END OF THE STENT WAS LOCATED APPROXIMATELY 0.5 MM PROXIMAL TO THE TIP. ALTHOUGH THE STENT WAS NOT COMPLETELY OFF THE BALLOON, THIS CONFIRMS THE REPORTED COMPLAINT THAT THE STENT HAD DISLODGED, CAUSING IT TO MOVE DISTALLY. THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS, INDICATING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. FURTHERMORE, DIMENSIONAL ANALYSIS WAS PERFORMED AND FOUND THAT THE OUTER DIAMETER OF THE STENT AT THE PROXIMAL END MET MANUFACTURING CRITERIA. ALTHOUGH THE MIDDLE AND DISTAL END WERE BOTH SLIGHTLY OVERSIZED AND ABOVE THE MAXIMUM SPECIFICATION, THIS WAS LIKELY DUE TO THE STENT DISLODGMENT AS IT IS EXPECTED THAT THE STENT MAY EXPAND DURING TRAVEL OVER THE BALLOON. IT IS POSSIBLE THAT SIGNIFICANT PRESSURE WAS INADVERTENTLY APPLIED DURING REMOVAL OF THE PROTECTIVE SHEATH SUCH THAT THE STENT BECAME DISRUPTED ON THE BALLOON AND DISLODGED/MOVED ON THE BALLOON, ALTHOUGH THIS CANNOT BE CONFIRMED. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE 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. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND THE ANALYSIS OF THE RETURNED PRODUCT, A DEFINITIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT CANNOT BE DETERMINED. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR STENT MOVEMENT TO VERIFY STENT SECURITY AND DISLODGMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT IMPLANT DISLODGED FROM THE BALLOON PRIOR TO USE. ANOTHER DEVICE WAS USED TO TREAT THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0091741

    Patients

    Seq Age Sex Outcome Treatment
    1