BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 3813448 · Received May 15, 2014

    Report

    Report Number
    2024168-2014-03080
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE FAILURE TO DEPLOY THE STENT COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON A VISUAL INSPECTION, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0 X 100 MM ABSOLUTE PRO WAS ADVANCED TO THE LESION AND AN ATTEMPT WAS MADE TO DEPLOY THE STENT; HOWEVER, THE THUMBWHEEL COULD NOT BE TURNED. THE DEVICE WAS REMOVED AND A NEW SAME SIZE ABSOLUTE PRO WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291348 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 2122161

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR