BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS (TM) LIBERTÉ (TM) LONG

    MDR report key: 2133178 · Received June 20, 2011

    Report

    Report Number
    2134265-2011-02345
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH PROXIMAL STENT DAMAGE. STRUT ROWS TOWARDS THE PROXIMAL END OF THE STENT WERE RAISED FROM THE BALLOON AND MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. 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. 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/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 100% STENOSED, 3.00X38MM DENOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.5X15MM MAVERICK BALLOON, LEAVING 90% RESIDUAL STENOSIS. THE PHYSICIAN ATTEMPTED TO ADVANCE A 3.00X38MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) TO THE RCA, IN A LESION DISTAL TO A PREVIOUSLY PLACED UNKNOWN STENT; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE PREVIOUSLY PLACED STENT. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE LESION WAS RE-DILATED. WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE SDS A SECOND TIME IT WAS NOTED THAT THE FRONT PART OF THE STENT HAD "DETACHED" FROM THE SDS; HOWEVER, THE STENT REMAINED ON THE STENT DELIVERY BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.0X38MM NON BSC STENT WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DISTAL EDGE OF THE 3.00X38MM TAXUS LIBERTE STENT WAS DAMAGED AND IT WAS NOTED THAT THE STENT APPEARED "DISSECTED".

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DISTAL EDGE OF THE 3.00X38MM TAXUS LIBERTE STENT WAS DAMAGED AND IT WAS NOTED THAT THE STENT APPEARED "DISSECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (TM) LIBERTÉ (TM) LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894038300 14010121

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR FR4 6F GUIDE CATHETER| CHOICE FLOPPY GUIDE WIRE| 2.5X15MM MAVERICK BALLOON CATHETER