BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3896585 · Received June 26, 2014

    Report

    Report Number
    2134265-2014-03549
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THERE WAS NO STENT RETURNED WITH THE DEVICE FOR EXAMINATION. THE BALLOON PROFILE WAS EXAMINED AND SHOWED EVIDENCE THAT THE STENT WAS CRIMPED ONTO THE BALLOON. THE BALLOON APPEARED TO HAVE BEEN INFLATED WHICH MAY INDICATE THAT THE STENT WAS DEPLOYED. THERE WAS CONTRAST MEDIA PRESENT THROUGHOUT THE BALLOON. A TACTILE AND VISUAL EXAMINATION FOUND THE UNIT NO DAMAGE TO THE TIP OR HYPOTUBE SECTIONS 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 PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTY OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 10MM IN LENGTH, ECCENTRIC AND TOTAL OCCLUSION TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED AND 3.5MM IN DIAMETER LEFT ANTERIOR DESCENDING ARTERY. A 12 X 3.50MM TAXUS¿ LIBERTÉ¿ STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, THE RETURNED DEVICE ANALYSIS REVEALED STENT DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373755 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894012350 16355624

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR