BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1840329 · Received September 21, 2010

    Report

    Report Number
    2134265-2010-04079
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT DEVICE EVALUATED BY MANUFACTURER - THE DEVICE WITH THE STENT WAS VISUALLY, TACTILELY AND MICROSCOPICALLY EXAMINED ALONG THE ENTIRE LENGTH. THE BALLOON WAS TIGHTLY FOLDED AND CRIMP MARKS WERE VISIBLE BETWEEN THE MARKERBANDS; HOWEVER, THE STENT MOVED APPROXIMATELY 0.5 MM DISTAL FROM THE AS-MANUFACTURED POSITION BETWEEN THE MARKERBANDS. MICROSCOPIC INSPECTION OF THE REMAINDER OF THE DEVICE ALSO PRESENTED TIP DAMAGE AND A SHAFT KINK LOCATED APPROXIMATELY 7.25 INCHES FROM DISTAL TIP. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT WAS UNABLE TO CROSS THE LESION. THE PATIENT PRESENTED WITH A NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED AT A BIFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A DIAGONAL ARTERY WHICH WAS HEAVILY CALCIFIED AND TORTUOUS. MULTIPLE GUIDES WERE USED IN AN ATTEMPT TO INTUBATE THE LEFT MAIN ARTERY. WIRES WERE THEN PASSED INTO BOTH THE DIAGONAL ARTERY AND THE LAD. THE LESION WAS PREDILATED WITH A 2.0X20MM APEX BALLOON. A 2.5X23MM PROMUS STENT AND A 2.5X18MM PROMUS STENT WERE ADVANCED IN PARALLEL IN ATTEMPT TO STENT THE DISTAL LAD AND THE DIAGONAL AT THE SAME TIME, BUT THE STENTS WOULD NOT CROSS EACH OTHER IN THE LAD. THE 2.5X18MM PROMUS STENT WAS PULLED BACK AND DEPLOYED IN THE PROXIMAL PORTION OF THE DIAGONAL ARTERY WHERE THE STENOSIS WAS MOST SEVERE. UPON REMOVAL OF THE STENT DELIVERY SYSTEM, RESISTANCE WAS FELT AND THE SHAFT BROKE OFF AT THE RAIL WERE THE WIRE EXITS. APPROXIMATELY 20CM OF THE STENT DELIVERY SYSTEM MIGRATED INTO THE LEFT CIRCUMFLEX ARTERY WITH THE PROXIMAL END IN THE LEFT MAIN ARTERY. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE FRACTURED DEVICE, BUT WERE UNSUCCESSFUL. A 2.5X23MM PROMUS STENT WAS DEPLOYED IN THE LEFT MAIN ARTERY TO SECURE THE FRACTURED CATHETER. MULTIPLE DEVICES WERE USED IN AN ATTEMPT TO TREAT THE LAD BUT COULD NOT CROSS THE LESION; INCLUDING, A 2.5X23MM PROMUS STENT, A 2.25X24MM TAXUS LIBERTE STENT, A 2.25X16MM TAXUS LIBERTE STENT, A 2.5X12MM PROMUS STENT, A 2.5X20MM APEX BALLOON AND A 1.5X20MM APEX BALLOON. AN INTRA-AORTIC BALLOON PUMP WAS PLACED AND THE PROCEDURE WAS COMPLETED AT THIS TIME. FLOW WAS RESTORED TO THE LEFT CIRCUMFLEX ARTERY, LAD AND DIAGONAL BUT SIGNIFICANT STENOSIS REMAINED. PROGNOSIS IS UNKNOWN AS THE PATIENT IS A POOR SURGICAL CANDIDATE; HOWEVER, THE PATIENT REMAINED HOSPITALIZED AND IN STABLE CONDITION. PRODUCT ANALYSIS FOUND THAT THE STENT HAD MOVED ON THE BALLOON OF THE 2.25X24MM TAXUS LIBERTE' STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893724220 12946382

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR (2) FORTE MS GUIDE WIRES| 7FR MACH CLS3 GUIDE CATHETER| 7FR WISEGUIDE FL3.5 GUIDE CATHETER| 6FR RUNWAY Q3.5 GUIDE CATHETER| 1.5X20MM APEX PUSH BALLOON| (2) 2.5X23MM PROMUS STENTS| EXPRO ELITE 10MM SNARE| 6FR RUNWAY KIMNY GUIDE CATHETER| (2) 2.0X20MM APEX BALLOONS| 6FR RUNWAY CLS 3.5 GUIDE CATHETER| 7FR WISEGUIDE 7L3 GUIDE CATHETER| 2.25-3.5MM FILTERWIRE EZ| CHOICE PT GUIDE WIRE| 7FR WISEGUIDE VL3.5 GUIDE CATHETER| CHOICE ES GUIDEWIRE| 2.25X16MM TAXUS LIBERTE' STENT| (2) 2.5X20MM APEX BALLOONS| 2.5X18MM PROMUS STENT| 2.5X12MM PROMUS STENT| (2) 6FR RUNWAY AL2 GUIDE CATHETERS