BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX HERCULINK ELITE STENT SYSTEM

    MDR report key: 2162196 · Received July 14, 2011

    Report

    Report Number
    2024168-2011-04960
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) FOUND BLOOD ON THE SHAFT, WHICH IS CONSISTENT WITH THE SDS BEING ADVANCED INTO THE ANATOMY. THERE WAS NO CONTRAST VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON BETWEEN THE MARKERS. THERE WERE STRETCHED STRUTS IN THE FIRST AND SECONDS ROWS OF THE PROXIMAL END OF THE STENT IMPLANT. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE STENT IMPLANT WAS NOT LOOSE AS REPORTED. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE SDS WAS RETURNED INSIDE A NON-ABBOTT GUIDING CATHETER AND A ABBOTT COPILOT. THE GUIDING CATHETER WAS RETURNED WITH BLOOD INSIDE AND ON THE SHAFT AND NO CONTRAST VISIBLE. THERE WAS NO DAMAGE NOTED TO THE RETURNED GUIDING CATHETER. THE COPILOT WAS RETURNED WITH BLOOD IN THE CAP AND NO CONTRAST VISIBLE. THERE WAS NO DAMAGE NOTED TO THE RETURNED COPILOT. THE COPILOT WAS RETURNED IN AN OPENED POSITION. A NON-ABBOTT GUIDE WIRE WAS RETURNED WITH BLOOD ON THE COILS AND NO CONTRAST VISIBLE. THERE WAS NO DAMAGE NOTED TO THE RETURNED GUIDE WIRE. MEASUREMENTS WERE TAKEN OF THE HERCULINK ELITE STENT IMPLANT OUTER DIAMETERS (DISTAL TO THE DAMAGE) AND THESE MET MANUFACTURING CRITERIA. DURING FUNCTIONAL TESTING, AN ATTEMPT WAS MADE TO REMOVE THE SDS FROM THE RETURNED GUIDING CATHETER. BUT THE SDS WOULD NOT REMOVE PAST THE STRETCHED STRUTS IN THE PROXIMAL END. BASED ON THE REPORTED INFORMATION AND RETURNED DEVICE ANALYSIS, IT APPEARS THAT DURING RETRACTION OF THE UNIT TO GET A BETTER POSITION, THE PROXIMAL END OF THE STENT CAUGHT ON THE GUIDE CATHETER CAUSING THE NOTED STENT DAMAGE TO THE PROXIMAL END OF THE STENT. THE STENT WAS NOT LOOSE ON THE BALLOON AS REPORTED. AS IT WAS REPORTED THAT DIRECT STENTING WAS BEING PERFORMED, IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTION FOR USE (IFU) STATES: STRICTURE AND BILE DUCTS MAY NEED TO BE PRE-DILATED WITH BALLOON DILATATION. PREDILATATION CATHETER DIAMETERS SHOULD CLOSELY MATCH THE DUCT DIAMETER PROXIMAL AND DISTAL TO THE STRICTURE TO BE TREATED. IN THIS CASE, IT COULD NOT BE DETERMINED IF THE FAILURE TO PRE-DILATE THE LESION CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTIES. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. OVERALL, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CASE CIRCUMSTANCES. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED FOR STENT DAMAGE, STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AFTER THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT ANATOMY THE STENT WAS NOTED TO BE LOOSE ON THE BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIRECT STENTING PROCEDURE OF THE RENAL ARTERY, THE HERCULINK ELITE STENT DELIVERY SYSTEM WAS RETRACTED TO GET A BETTER POSITION IN THE VESSEL WHEN THE STENT BECAME CAUGHT ON THE CATHETER TIP. THE STENT SYSTEM WAS REMOVED WITH THE GUIDE CATHETER WITHOUT REPORTED INCIDENT. REPORTEDLY, THERE WAS A CLINICALLY SIGIFICANT DELAY OF 30 MINUTES IN THE PROCEDURE DUE TO THE DEVICE ISSUE. A SECOND DEVICE WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN 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 9111051

    Patients

    Seq Age Sex Outcome Treatment
    1