BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3240298 · Received July 22, 2013

    Report

    Report Number
    2134265-2013-04888
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 24, 2013
    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 EVALUATED BY MFR: VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THAT THE STENT WAS DAMAGED. THE STENT WAS STRETCHED ALONG ITS LENGTH CAUSING SOME OF THE STRUTS TO BE RAISED UP. THE BALLOON AND THE TIP 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 ANY POSITIVE PRESSURE. NO KINKS OR DAMAGE WAS NOTED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH 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 ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, FAILURE TO CROSS THE LESION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PRE-DILATED WITH APEX DILATATION CATHETER @ 16ATM. A 32 X 2.25MM TAXUS LIBERTÉ MONORAIL DRUG ELUTING STENT SYSTEM WAS ADVANCED TO CROSS THE LESION. SEVERAL ATTEMPTS AT CROSSING THE LESION WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS¿ CONDITION IS LISTED AS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341136 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894032220 15300623

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR