BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1994439 · Received February 17, 2011

    Report

    Report Number
    2134265-2011-00216
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE CATHETER WAS VISUALLY EXAMINED AND FOUND THE DEVICE IN TWO PIECES. THE ENDS OF THE HYPO-TUBE SEPARATION APPEAR TO BE OVAL WHICH IS CONSISTENT WITH THE DEVICE HAVING BEEN KINKED. THE PROXIMAL PORTION MEASURED 6CM FROM THE MANIFOLD STRAIN RELIEF AND THE DISTAL PORTION WAS 148CM IN LENGTH. THE BALLOON PORTION OF THE DEVICE WAS NOT RETURNED AND IT WAS CONFIRMED WITH THE FACILITY THAT THIS WAS DISPOSED. THE DISTAL SEPARATION APPEARS TO BE STRETCHED AND JAGGED. MULTIPLE KINKS AND BENDS WERE FOUND THROUGHOUT THE HYPO-TUBE. THE MIDSHAFT WAS STRETCHED 8.5CM PROXIMAL STARTING AT THE GUIDEWIRE EXIT NOTCH. THE DISTAL PORTION OF THE DEVICE WAS ALSO STRETCHED STARTING 11CM FROM THE DISTAL BREAK. 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH A 3.25X10MM NON-BSC BALLOON. NEXT, A 16X3.5MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A NON-BSC GUIDE CATHETER. HOWEVER, WHEN THE SDS EXITED THE GUIDE CATHETER IT GOT STUCK. SINCE IT WAS NOT POSSIBLE TO REMOVE THE SDS, THE DEVICES WERE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS DETACHED WHEN PUSHING THE DEVICE WITHIN A MICRO CATHETER. THE BROKEN PORTION WAS WITHIN THE MICROCATHETER AND WAS REMOVED WITH THE MICROCATHETER.

    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 H7493893616350 12877550

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO RUNTHROUGH| COOK'S GUIDE CATHETER| TERUMO'S HIRYU 3.25-10 BALLOON