BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK OTW VISION CORONARY STENT SYSTEM

    MDR report key: 3770975 · Received April 24, 2014

    Report

    Report Number
    2024168-2014-02559
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 31, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES OR EXCEPTIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PROTECTIVE SHEATH WAS REMOVED FROM THE 3.5X28 MM VISION STENT DELIVERY SYSTEM, WITH NO RESISTANCE FELT DURING REMOVAL OF THE SHEATH, THE STENT IMPLANT FELL OFF THE BALLOON INTO THE TECHNICIANS HAND. THE DEVICE WAS NOT USED ON THE PATIENT. A NEW SAME SIZE VISION WAS ABLE TO BE USED SUCCESSFULLY WITHOUT FURTHER ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249705 MULTI-LINK OTW VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2041241

    Patients

    Seq Age Sex Outcome Treatment
    1