BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1905113 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05081
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 2, 2010
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS). THE ENTIRE LENGTH OF THE STENT WAS DAMAGED WITH THE STRUTS BEING MISALIGNED AND SQUASHED. THERE WAS HUMAN TISSUE, MOST LIKELY FROM THE PATIENT, WRAPPED AROUND THE STENT STRUTS AT ONE POINT. THE TISSUE WAS NOT SENT FOR PATHOLOGICAL TESTING AS THE NO PATIENT COMPLICATIONS WERE REPORTED AT THIS TIME. THERE WERE KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THE 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 ANY POSITIVE PRESSURE. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSION ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. 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 90% STENOSED TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). AFTER PREDILATING THE LESION, A 5.0X24MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT WOULD NOT CROSS THE LESION. AFTER SEVERAL ATTEMPTS TO CROSS THE LESION, THE DEVICE WAS REMOVED AND IT WAS NOTED THAT A STENT STRUT WAS DAMAGED. TO COMPLETE THE PROCEDURE THE PHYSICIAN DILATED THE LESION AGAIN AND USED ANOTHER OF THE SAME SDS. NO PATIENT COMPLICATIONS WERE REPORTED 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 90% STENOSED TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). AFTER PREDILATING THE LESION, A 5.0X24MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT WOULD NOT CROSS THE LESION. AFTER SEVERAL ATTEMPTS TO CROSS THE LESION, THE DEVICE WAS REMOVED AND IT WAS NOTED THAT A STENT STRUT WAS DAMAGED. TO COMPLETE THE PROCEDURE THE PHYSICIAN DILATED THE LESION AGAIN AND USED ANOTHER OF THE SAME SDS. 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 LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894024500 0013135497

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR