BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2012926 · Received March 10, 2011

    Report

    Report Number
    2134265-2011-00684
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A MONORAIL (MR) TAXUS LIBERTE SDS (STENT DELIVERY SYSTEM). THE BALLOON WAS TIGHTLY FOLDED WITH CRIMP MARKS SHOWING EVIDENCE OF THE STENT SECUREMENT. MAGNIFIED AND TACTILE INSPECTION OF THE SDS AND STENT IMPLANT REVEALED NO IRREGULARITIES OR DAMAGE. THE STENT IMPLANT WAS RECEIVED DETACHED FROM THE SDS. THERE WAS NO EVIDENCE OF ANY MATERIAL DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE STENT DETACHMENT. THE OUTER DIAMETER OF THE OF THE STENT WAS WITHIN SPECIFICATION. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-00913. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE LESION WAS LOCATED IN THE LCX (LEFT CIRCUMFLEX) ARTERY WITH A 90 DEGREE ANGLE BEFORE THE LESION. THE PHYSICIAN PREDILATED AND ATTEMPTED TO DELIVER THE 2.25X28MM TAXUS LIBERTE ATOM STENT TO THE LESION. HOWEVER, THE LESION WAS TOO TORTUOUS AND THE STENT DELIVERY SYSTEM WAS UNABLE TO CROSS. THE STENT DELIVERY SYSTEM WAS PULLED BACK INTO THE GUIDE CATHETER AND REMOVED. THE STENT DISLODGED OUTSIDE THE PATIENT. ANOTHER ATTEMPT TO TREAT THE LESION WAS MADE WITH A 2.25X16MM TAXUS LIBERTE ATOM STENT; HOWEVER, IT WAS ALSO UNABLE TO CROSS THE LESION. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-00913. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE LESION WAS LOCATED IN THE LCX (LEFT CIRCUMFLEX) ARTERY WITH A 90 DEGREE ANGLE BEFORE THE LESION. THE PHYSICIAN PREDILATED AND ATTEMPTED TO DELIVER THE 2.25X28MM TAXUS LIBERTE ATOM STENT TO THE LESION. HOWEVER, THE LESION WAS TOO TORTUOUS AND THE STENT DELIVERY SYSTEM WAS UNABLE TO CROSS. THE STENT DELIVERY SYSTEM WAS PULLED BACK INTO THE GUIDE CATHETER AND REMOVED. THE STENT DISLODGED OUTSIDE THE PATIENT. ANOTHER ATTEMPT TO TREAT THE LESION WAS MADE WITH A 2.25X16MM TAXUS LIBERTE ATOM STENT; HOWEVER, IT WAS ALSO UNABLE TO CROSS THE LESION. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628220 13548137

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR