BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 3851163 · Received June 5, 2014

    Report

    Report Number
    2024168-2014-03590
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED. DATE OF IMPLANT ESTIMATED. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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 PART AND LOT NUMBERS WERE NOT REPORTED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. EARLY THROMBOSIS MAY BE DUE TO, BUT NOT LIMITED TO, INADEQUATE INTENSITY OF ANTI-PLATELET THERAPY OR PREMATURE CESSATION OF ANTI-PLATELET THERAPY, OR HIGH PLATELET REACTIVITY. IN THIS CASE, THE REPORTED EARLY THROMBOSIS WAS NOT SPECIFICALLY IDENTIFIED FOR A SPECIFIC INCIDENT, BUT WAS REPORTED AS GENERAL COMMENT; THEREFORE, A CONCLUSIVE CAUSE FOR THE ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS IS A GENERAL COMMENT FROM FOUR PHYSICIANS REGARDING THEIR EXPERIENCE WITH THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS). THE FOLLOWING EXPERIENCES WERE: LOW RADIAL FORCE. DIFFICULTY DEPLOYING STENT IN UP AND OVER (CONTRA-LATERAL) PROCEDURES. IMPRECISE DEPLOYMENT IN EXTREMELY TIGHT LESIONS. DIFFICULTY CROSSING BALLOON ONCE STENT IS DEPLOYED IN BUDDING ATHEROMAS. THIS SEEMS DUE TO THE STENT CONFIGURATION AND POSSIBLY ITS RADIAL FORCE, LEAVING DISPARITIES THAT SEEM TO HOOK ON TO MATERIALS GOING THROUGH STENT (BALLOONS AND WIRES). DECREASED VISIBILITY ON INSERTION, OF SHEATH COVERING STENT AND OF STENT IN VERY OBESE PATIENTS. EARLY (PRECOCIOUS) THROMBOSIS OF STENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329947 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention