BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK ELITE STENT SYSTEM

    MDR report key: 2060373 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02686
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION POTENTIAL FACTORS THAT COULD CONTRIBUTE TO STENT DISLODGMENT INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREP, INTERACTION WITH ACCESSORY DEVICES, INTERACTION WITH THE LESION, TORTUOUS ANATOMY, OR HEAVY CALCIFICATIONS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE DISLODGMENT COULD NOT BE DETERMINED, IT MAY BE POSSIBLE THAT INTERACTION/RESISTANCE WITH THE SHEATH AS IT EXITED THE SHEATH. CINE IMAGES OF THE PROCEDURE WERE REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST. THE RESULTS SHOW ONE STILL IMAGE SHOWING A STENT DISLODGED PROXIMALLY SO THAT IT IS POSITIONED PARTIALLY ON THE BALLOON AND PARTIALLY ON THE SHAFT OF THE DELIVERY SYSTEM. THE IMAGE CONFIRMS THAT THE STENT DISLODGED FROM THE BALLOON. IN THIS CASE, WITHOUT HAVING THE PRODUCT FOR EVALUATION, A CONCLUSIVE CAUSE FOR THE REPORTED DISLODGMENT COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED FOR PROPER STENT PLACEMENT AND STENT DAMAGE, AND ARE DIMENSIONALLY INSPECTED FOR CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, SAMPLES ARE REMOVED FROM EACH LOT FOR DESTRUCTIVE STENT DISLODGEMENT TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HERCULINK ELITE STENT DELIVERY SYSTEM DISLODGED FROM THE BALLOON PROXIMAL TO THE TARGET LESION AFTER BEING ADVANCED THROUGH THE NON-ABBOTT SHEATH IN THE MODERATELY CALCIFIED, LEFT DESCENDING RENAL ARTERY. THE DELIVERY SYSTEM WAS MANIPULATED SO THE DISLODGED STENT WAS PLACED AND DEPLOYED IN THE PROXIMAL PART OF THE TARGET LESION. A SECOND HERCULINK ELITE STENT WAS PLACED DISTAL TO THE STENT OVERLAPPING BY 5MM. THE STENOSIS WAS COVERED BY THE 2 STENTS. LESION LENGTH WAS 8-9MM. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX HERCULINK ELITE STENT SYSTEM BILIARY STENT SYSTEM FGE AV-TEMECULA-CT 0071451

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: ARROWFLEX