BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2904649 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08159
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 15, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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

    DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATION: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL STENT DAMAGE. ONE STRUT WAS MISALIGNED NEAR THE PROXIMAL EDGE OF THE STENT. THE CRIMPED STENT, BALLOON AND TIP 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. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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 AND/OR PROCEDURAL FACTORS. (B)(4) .

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT CORONARY STENTING TREATMENT PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 2.2X 15MM, 90% STENOTIC, ECCENTRIC SHAPED, DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THERE WAS A SIGNIFICANT BEND > 90 DEGREES INVOLVED INT HE LESION. THE PHYSICIAN PREDILATED THE LESION WITH A 2.0X15MM NON-BSC BALLOON WITH FOUR INFLATIONS AT 14ATMS FOR EIGHT SECONDS EACH. THE PHYSICIAN THEN ADVANCED A 2.25X12MM TAXUS LIBERTE STENT TO THE LESION, BUT WAS UNABLE TO CROSS. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.25X12MM TAXUS LIBERTE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, THE PRODUCT ANALYSIS ON THE RETURNED DEVICE REVEALED THAT THE STENT WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10827 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894012220 14885586

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR 0.014" HT BMW UNIVERSAL GUIDE WIRE - 190 CM| 0.014" PILOT 50 GUIDE WIRE -190CM| 6F EBU3.5 LAUNCHER GUIDE CATHETER| 2.0X15MM RYUJIN BALLOON CATHETER