BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2972322 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00930
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED THE STENT WAS CENTERED BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON; THERE WAS NO INDICATION THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. THE SEVENTH STENT STRUT ROW FROM THE DISTAL END OF THE STENT HAD ONE STENT STRUT STRETCHED AND BENT. MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. 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

    DEVICE IS COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. RESISTANCE WAS NOTED WHILE ADVANCING THE 2.5X16MM TAXUS LIBERTE CORONARY DRUG-ELUTING STENT SYSTEM WITHIN AN UNSPECIFIED GUIDE CATHETER. THE DEVICE WAS WITHDRAWN AND A RAISED STENT STRUT WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE TARGET LESION DETAILS ARE UNKNOWN. RESISTANCE WAS NOTED WHILE ADVANCING THE 2.5X16MM TAXUS LIBERTE CORONARY DRUG-ELUTING STENT SYSTEM WITHIN AN UNSPECIFIED GUIDE CATHETER. THE DEVICE WAS WITHDRAWN AND A RAISED STENT STRUT WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76182 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894016250 15349407

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR