BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2000528 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01124
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE HYPOTUBE AND DISTAL SHAFT. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON. THIS IS CONSISTENT WITH HANDLING, PREPARATION, AND THE SDS ADVANCED OVER A GUIDE WIRE. THE STENT WAS RETURNED DISLODGED FROM THE SDS, CONFIRMING THE REPORTED INFORMATION. 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 MANUFACTURE. 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 INNER DIAMETER OF THE PROTECTIVE SHEATH AND THE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. IT IS POSSIBLE THE STENT WAS INADVERTENTLY HANDLED DURING PREPARATION FOR USE, RESULTING IN THE STENT DISLODGING HOWEVER THIS COULD NOT BE CONFIRMED. 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. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR STENT DISLODGEMENTS FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. 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 WHEN THE STYLET WAS REMOVED FROM THE VISION STENT DELIVERY SYSTEM (SDS), THE VISION STENT FELL OFF ON THE TABLE. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER VISION WAS USED WITHOUT FURTHER INCIDENT. THERE WAS NO ADDITIONAL INFORMATION 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 8120541

    Patients

    Seq Age Sex Outcome Treatment
    1