BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK ELITE STENT SYSTEM

    MDR report key: 2122228 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04144
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONLY THE DISLODGED STENT IMPLANT WAS RETURNED. THERE WAS BLOOD ON THE STENT IMPLANT, CONSISTENT WITH BEING IN THE ANATOMY. THERE WAS NO CONTRAST VISIBLE. THE ENTIRE LENGTH OF THE STENT WAS MANGLED. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY ISSUE. IN THIS CASE, IT WAS REPORTED THAT THE LESION WAS HEAVILY CALCIFIED AND WAS NOT PRE-DILATED, WHICH MAY HAVE CONTRIBUTED TO THE CROSSING DIFFICULTY. ADDITIONALLY, IT WAS REPORTED THAT THE STENT SYSTEM WAS REMOVED FROM THE ANATOMY AND PRE-DILATATION WAS PERFORMED. IT SHOULD BE NOTED THAT A PRECAUTION LISTED IN THE PRODUCT INSTRUCTIONS FOR USE STATES: DO NOT ATTEMPT TO PULL AN UNEXPANDED STENT BACK THROUGH THE INTRODUCER SHEATH/GUIDING CATHETER; DISLODGMENT OF THE STENT FROM THE BALLOON MAY OCCUR. IN THIS CASE, IT MAY BE POSSIBLE THAT BY PULLING THE HERCULINK ELITE BACK INTO THE INTRODUCER SHEATH TO PERFORM PRE-DILATATION, THE STENT MAY HAVE BECOME LOOSE ON THE BALLOON, AND DURING THE SECOND ATTEMPT TO CROSS THE LESION, THE STENT FULLY DISLODGED. TO ENSURE THIS IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR PROPER STENT PLACEMENT AND STENT DAMAGE, AND ARE 100% DIMENSIONALLY INSPECTED FOR CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, SAMPLES ARE REMOVED FROM EACH LOT FOR DESTRUCTIVE STENT DISLODGEMENT TESTING. AS A RESULT OF THE DISLODGMENT, THE STENT TRAVELED TO THE COMMON FEMORAL ARTERY WHERE IT WAS SUCCESSFULLY RETRIEVED FROM THE ANATOMY USING A NON-ABBOTT RETRIEVAL DEVICE, WHICH IS CONSISTENT WITH THE DAMAGED CONDITION OF THE RETURNED STENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS 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. THE REPORTED FAILURE TO CROSS AND SUBSEQUENT STENT DISLODGMENT APPEARS TO BE RELATED TO CASE CIRCUMSTANCES. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    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 REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED RIGHT RENAL ARTERY, PRE-DILATATION WAS NOT PERFORMED AND AN UNSUCCESSFUL ATTEMPT WAS MADE TO ADVANCE A 6.0X15 RX HERCULINK ELITE STENT SYSTEM. THE STENT SYSTEM WAS REMOVED FROM THE ANATOMY AND PRE-DILATATION WAS PERFORMED. A SECOND ATTEMPT WAS MADE TO ADVANCE THE STENT SYSTEM; HOWEVER, THE STENT DISLODGED WHILE CROSSING THE LESION. THE STENT TRAVELED TO THE COMMON FEMORAL ARTERY WHERE IT WAS SUCCESSFULLY RETRIEVED FROM THE ANATOMY USING A NON-ABBOTT RETRIEVAL DEVICE. A NEW 6.0X18 HERCULINK ELITE STENT SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION IN THE RENAL ARTERY AND THE STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. ALTHOUGH THERE WAS NO ADVERSE PATIENT SEQUELA, THERE WAS A SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS 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 0111551

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention GUIDE WIRE: STABILIZER PLUS