BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2061414 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01256
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 22, 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

    (B)(4). DEVICE EVALUATED BY MFR: THE TAXUS LIBERTE SDS DEVICE WAS RECEIVED FOR ANALYSIS IN TWO PIECES. THE PROXIMAL PIECE MEASURED 89.5CM AND THE DISTAL PIECE MEASURED 62CM. CONTRAST WAS PRESENT ON THE DEVICE. THE FRACTURE SURFACES ARE CONSISTENT WITH A FRACTURE DUE TO TENSILE OVERLOAD. EXAMINATION OF THE MATERIAL SURROUNDING THE SEPARATION AND DAMAGE DID NOT REVEAL ANY EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. MICROSCOPIC INSPECTION OF THE REMAINDER OF THE DEVICE 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

    THIS COMPLAINT IS NOW REPORTABLE BASED ON RETURNED DEVICE ANALYSIS COMPLETED (B)(4)-2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE THE DEVICE FAILED TO CROSS THE LESION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A TAXUS LIBERTE LONG, (MR) 38 X 2.75MM STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE LESION AS THE PATIENT'S ANATOMY WAS "TOO TORTUOUS". THE PHYSICIAN ELECTED TO END THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED A SHAFT BREAK.

    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 H7493893638270 13704993

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR