BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2151774 · Received July 6, 2011

    Report

    Report Number
    2134265-2011-02842
    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
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RECEIVED PRODUCT CONSISTED OF A TAXUS ELEMENT/ION STENT DELIVERY SYSTEM (SDS) WITHOUT THE STENT THE RECEIVED DEVICE WAS IN TWO PIECES, SEPARATED AT THE MID-SHAFT. THE DISTAL PORTION HAD AN OVERALL LENGTH OF 36.7 CM (POINT OF SEPARATION TO THE TIP), OF WHICH 11.5 CM WAS THE MID-SHAFT (FROM GUIDEWIRE EXIT NOTCH TO POINT OF SEPARATION). THE PROXIMAL PORTION HAD AN OVERALL LENGTH OF 133 CM (POINT OF SEPARATION TO THE END OF THE MANIFOLD), OF WHICH 18 CM WAS THE MID-SHAFT (FROM THE POINT OF SEPARATION TO THE MID-SHAFT BOND). BOTH PORTIONS OF THE MID-SHAFT WERE STRETCHED. THE BALLOON HAS HAD POSITIVE PRESSURE INTRODUCED AND HAD EVIDENCE OF A STENT HAVING BEEN SECURED IN THE PROPER LOCATION DURING MANUFACTURING. DRIED BLOOD AND CONTRAST WAS PRESENT ON THE INSIDE AND OUTSIDE OF THE DEVICE. FURTHER INSPECTION PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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).

    Description of Event or Problem · 1

    SAME CASE AS MFR ID#: 2134265-2011-02841. 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#: 2134265-2011-02841. 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 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420220

    Patients

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