BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM

    MDR report key: 4101926 · Received September 19, 2014

    Report

    Report Number
    2024168-2014-06043
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    June 26, 2014
    Report Date
    August 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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 TREATING A MILDLY TORTUOUS, MODERATELY CALCIFIED, 80% STENOSED, DE NOVO LESION IN THE MID FEMORAL ARTERY. THE 6.0X150MM ABSOLUTE PRO LL WAS DEPLOYED IN THE LESION AND THE STENT WAS NOTED TO BE KINKED AND THE DISTAL STENT STRUTS WERE FLARED. DUE TO THE FLARED STENT STRUTS, A SUPERA STENT WAS IMPLANTED, OVERLAPPING THE ABSOLUTE STENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581995 ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 3101761

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention