BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK ELITE STENT SYSTEM

    MDR report key: 3900652 · Received June 27, 2014

    Report

    Report Number
    2024168-2014-04182
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIN
    PMA / PMN Number
    P110001
    Adverse Event
    Yes
    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. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. A QUERY 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 DURING HERCULINK ELITE STENT DEPLOYMENT, THE STENT JUMPED FORWARD, TO AN UNINTENDED SITE, WITHIN THE RENAL ARTERY. AN ARMADA DILATATION CATHETER WAS ABLE TO FULLY APPOSE THE STENT TO THE UNINTENDED AREA. ANOTHER HERCULINK SUCCESSFULLY COVERED THE RENAL ARTERY LESION. THERE WAS NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377989 RX HERCULINK ELITE STENT SYSTEM RENAL STENT SYSTEM NIN AV-TEMECULA-CT 3111261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention