BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (TM) LIBERTÉ (TM)

    MDR report key: 2221516 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03463
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM WITH NO ORIGINAL PACKAGING. THERE WAS NOT ANY BLOOD OR CONTRAST VISIBLE. THE BALLOON WAS TIGHTLY FOLDED WITH STENT STRUT IMPRESSIONS ON THE SURFACE OF THE BALLOON. THERE WAS ONE FLARED STRUT IN THE EIGHTH DISTAL ROW. THERE WAS NO OTHER DAMAGE TO THE STENT. THERE WAS NO DAMAGE TO THE STENT DELIVERY SYSTEM. THERE WAS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS IDENTIFIED. UPON UNPACKING THE 20X4.50MM TAXUS LIBERTE STENT DELIVERY SYSTEM IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE DEVICE DID NOT ENTER THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS IDENTIFIED.UPON UNPACKING THE 20X4.50MM TAXUS LIBERTE STENT DELIVERY SYSTEM IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE DEVICE DID NOT ENTER THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (TM) LIBERTÉ (TM) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894020450 13781569

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR