BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (TM) LIBERTÉ (TM)

    MDR report key: 2170469 · Received July 21, 2011

    Report

    Report Number
    2134265-2011-02831
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED STENT DAMAGE. A NUMBER OF STRUT ROWS AT THE DISTAL AND PROXIMAL ENDS OF THE STENT WERE RAISED AND MISALIGNED. THE TIP AND BALLOON SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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, STENT DAMAGE OCCURRED. THE TIGHT TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX (LCX). AFTER PREDILATING THE LESION, A 20X2.50MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. IT WAS NOTED THAT THE STENT STRUT WAS RAISED AND IT WAS EXCHANGED WITH ANOTHER OF THE SAME TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TIGHT TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX (LCX). AFTER PREDILATING THE LESION, A 20X2.50MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. IT WAS NOTED THAT THE STENT STRUT WAS RAISED AND IT WAS EXCHANGED WITH ANOTHER OF THE SAME TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS 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 - GALWAY H7493894020250 13890477

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR