BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3760109 · Received April 18, 2014

    Report

    Report Number
    2024168-2014-02479
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    October 20, 2013
    Report Date
    December 10, 2013
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED KINK WAS CONFIRMED. ADDITIONALLY, THE HYPOTUBE WAS SEPARATED DISTAL TO THE EDGE OF THE STRAIN RELIEF TUBING. BASED ON THE RETURNED DEVICE ANALYSIS, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REMOVAL OF THE PROTECTIVE SHEATH FROM THE 2.75X23 MM VISION STENT DELIVERY SYSTEM (SDS), A KINK IN THE PROXIMAL END OF THE SHAFT WAS OBSERVED NEAR TO THE INDEFLATOR CONNECTION. THE DEVICE WAS NOT USED ON THE PATIENT. A NEW SDS WAS USED SUCCESSFULLY TO COMPLETE THE CASE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED THE PROXIMAL SHAFT OF THE STENT DELIVERY SYSTEM WAS SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237525 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3040341

    Patients

    Seq Age Sex Outcome Treatment
    1