BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX HERCULINK ELITE STENT SYSTEM

    MDR report key: 3882019 · Received June 18, 2014

    Report

    Report Number
    2024168-2014-03911
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIN
    PMA / PMN Number
    P110001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MESENTERIC VESSEL. IT WAS REPORTED THAT WHILE ATTEMPTING TO REPOSITION THE 6.0 X 15 MM HERCULINK ELITE STENT SYSTEM, THE PROXIMAL EDGE OF THE STENT CAUGHT ON THE DISTAL TIP OF THE GUIDING CATHETER, AND SLIPPED FORWARD OFF THE STENT DELIVERY BALLOON. THE STENT AND STENT SYSTEM WERE REMOVED TOGETHER WITH THE STENT STILL ON THE DISTAL END OF THE SYSTEM, AND A NEW STENT WAS IMPLANTED WITHOUT ISSUE WITH A GOOD RESULT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358989 RX HERCULINK ELITE STENT SYSTEM STENT SYSTEM NIN AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR