BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R) ATOM (TM)

    MDR report key: 2151764 · Received July 6, 2011

    Report

    Report Number
    2134265-2011-02841
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS). THERE WERE STENT STRUT IMPRESSIONS ON THE SURFACE OF THE TIGHTLY FOLDED BALLOON. THE STENT WAS LOOSE IN THE RETURNED PACKAGING (DETACHED FROM THE SDS). THERE WAS A BLOOD LIKE SUBSTANCE ON THE STENT. THE LENGTH OF STENT WAS COMPRESSED FROM 20 MM TO 10 MM BECAUSE OF THE DAMAGE TO THE STENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR ID#: 2134265-2011-02842. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE AND STENT DISLODGEMENT OCCURRED. ACCESS WAS GAINED VIA A 6F NON-BSC SHEATH AND A 6F JL4 RUNWAY GUIDE CATHETER. THE DE NOVO TARGET LESIONS WERE LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED OSTIAL RAMUS AND OSTIAL LEFT CIRCUMFLEX (LCX) ARTERIES. THE RAMUS WAS 90% STENOSED AND THE LCX WAS 99% STENOSED AND WERE BOTH APPROXIMATELY 20MM LONG. THE PHYSICIAN PLANNED TO CARRY OUT A KISSING STENT TECHNIQUE. 2 PT MODERATE SUPPORT J GUIDE WIRES WERE ADVANCED, 1 DOWN THE OSTIAL LCX AND THE OTHER DOWN THE OSTIAL RAMUS. A 2.25X20MM ION STENT DELIVERY SYSTEM WAS ADVANCED AND POSITIONED IN THE OSTIAL LCX BUT NOT DEPLOYED. A 2.25X20MM TAXUS LIBERTE ATOM WAS THEN ADVANCED TO THE RAMUS, BUT WAS UNABLE TO CROSS THE LESION. THE UNDEPLOYED TAXUS LIBERTE STENT DELIVERY SYSTEM WAS PULLED BACK INTO THE GUIDE CATHETER AND THE ION STENT WAS SUCCESSFULLY DEPLOYED IN THE LCX. THE ION STENT DELIVERY CATHETER WAS PULLED BACK INTO THE GUIDE CATHETER, AND GOT CAUGHT ON THE UNDEPLOYED TAXUS LIBERTE STENT. THE ION STENT DELIVERY SYSTEM THEN BROKE OFF INSIDE THE GUIDE CATHETER. THE BROKEN FRAGMENT REMAINED INSIDE THE GUIDE CATHETER AND THE ENTIRE SYSTEM WAS REMOVED WITH NO DEVICE FRAGMENTS LEFT IN THE PATIENT. ONCE OUTSIDE, IT WAS OBSERVED THAT A VERY SMALL PORTION OF THE ION STENT DELIVERY CATHETER HAD BROKE OFF IN AN AREA WHERE THE SHAFT HAD STRETCHED. FURTHERMORE, THE TAXUS LIBERTE STENT HAD DISLODGED AND WAS STUCK TO THE BROKEN PIECE FROM THE ION STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED BY RE-WIRING THE VESSEL AND A PROMUS STENT WAS DEPLOYED IN THE RAMUS. THE FINAL OUTCOME WAS 0% RESIDUAL STENOSIS FOR BOTH LESIONS AND THE PATIENT CONDITION POST PROCEDURE WAS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MFR ID#: 2134265-2011-02842. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE AND STENT DISLODGEMENT OCCURRED. ACCESS WAS GAINED VIA A 6F NON-BSC SHEATH AND A 6F JL4 RUNWAY GUIDE CATHETER. THE DE NOVO TARGET LESIONS WERE LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED OSTIAL RAMUS AND OSTIAL LEFT CIRCUMFLEX (LCX) ARTERIES. THE RAMUS WAS 90% STENOSED AND THE LCX WAS 99% STENOSED AND WERE BOTH APPROXIMATELY 20MM LONG. THE PHYSICIAN PLANNED TO CARRY OUT A KISSING STENT TECHNIQUE. 2 PT MODERATE SUPPORT J GUIDE WIRES WERE ADVANCED, 1 DOWN THE OSTIAL LCX AND THE OTHER DOWN THE OSTIAL RAMUS. A 2.25X20MM ION STENT DELIVERY SYSTEM WAS ADVANCED AND POSITIONED IN THE OSTIAL LCX BUT NOT DEPLOYED. A 2.25X20MM TAXUS LIBERTE ATOM WAS THEN ADVANCED TO THE RAMUS, BUT WAS UNABLE TO CROSS THE LESION. THE UNDEPLOYED TAXUS LIBERTE STENT DELIVERY SYSTEM WAS PULLED BACK INTO THE GUIDE CATHETER AND THE ION STENT WAS SUCCESSFULLY DEPLOYED IN THE LCX. THE ION STENT DELIVERY CATHETER WAS PULLED BACK INTO THE GUIDE CATHETER, AND GOT CAUGHT ON THE UNDEPLOYED TAXUS LIBERTE STENT. THE ION STENT DELIVERY SYSTEM THEN BROKE OFF INSIDE THE GUIDE CATHETER. THE BROKEN FRAGMENT REMAINED INSIDE THE GUIDE CATHETER AND THE ENTIRE SYSTEM WAS REMOVED WITH NO DEVICE FRAGMENTS LEFT IN THE PATIENT. ONCE OUTSIDE, IT WAS OBSERVED THAT A VERY SMALL PORTION OF THE ION STENT DELIVERY CATHETER HAD BROKE OFF IN AN AREA WHERE THE SHAFT HAD STRETCHED. FURTHERMORE, THE TAXUS LIBERTE STENT HAD DISLODGED AND WAS STUCK TO THE BROKEN PIECE FROM THE ION STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED BY RE-WIRING THE VESSEL AND A PROMUS STENT WAS DEPLOYED IN THE RAMUS. THE FINAL OUTCOME WAS 0% RESIDUAL STENOSIS FOR BOTH LESIONS AND THE PATIENT CONDITION POST PROCEDURE WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) ATOM (TM) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620220 14191424

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention PT MODERATE SUPPORT J GUIDE WIRE X2| 2.25X20MM ION STENT| 6F TERUMO SHEATH| 6F JL4 RUNWAY GUIDE CATHETER