BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2083347 · Received May 10, 2011

    Report

    Report Number
    2134265-2011-01749
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE RECEIVED DEVICE WAS IN TWO PIECES, SEPARATED IN THE HYPO-TUBE PORTION 23.2 CM FROM THE STRAIN RELIEF. THE DISTAL PORTION OF THE HYPO-TUBE WAS KINKED 1.2 CM FROM THE SEPARATION. THE FRACTURE FACES WERE OVAL SHAPED. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT BETWEEN THE MARKERBANDS. 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. A 16X2.75MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND WHILE TRYING TO CROSS THE LESION THE SHAFT BROKE ON A PORTION OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. A 16X2.75MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND WHILE TRYING TO CROSS THE LESION THE SHAFT BROKE ON A PORTION OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED.

    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 H7493893616270 13862844

    Patients

    Seq Age Sex Outcome Treatment
    1