BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 3870579 · Received June 12, 2014

    Report

    Report Number
    2024168-2014-03768
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 19, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: 0.035 RADIFOCUS; GUIDE CATHETER: DESTINATION 6F. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED AND MODERATELY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. AN ATTEMPT WAS MADE TO ADVANCE THE ABSOLUTE PRO 10X60MM STENT DELIVERY SYSTEM (SDS) INTO THE ANATOMY, BUT THE DISTAL END OF THE STENT WAS FOUND TO BE SLIGHTLY EXPOSED AT THE END OF THE SHEATH. THE ABSOLUTE PRO SDS WAS NOT USED FOR THE PROCEDURE. A NEW ABSOLUTE PRO WAS USED FOR THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348846 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 4021761

    Patients

    Seq Age Sex Outcome Treatment
    1