BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1760817 · Received July 19, 2010

    Report

    Report Number
    2134265-2010-03067
    Event Type
    Injury
    Date Received
    July 19, 2010
    Report Date
    June 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE MONORAIL (MR) STENT DELIVERY SYSTEM (SDS) WITH NO STENT. BLOOD AND CONTRAST WERE VISIBLE IN THE DISTAL AND MIDSHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS USED. THE RETURNED CATHETER WAS VISUALLY, TACTILELY EXAMINED ALONG THE ENTIRE LENGTH AND THE ONLY DAMAGE SEEN WAS ON THE DISTAL END. THE DISTAL END WAS FURTHER INSPECTED UNDER MAGNIFICATION AND IT WAS DETERMINED THAT THE STENT WAS NO LONGER PRESENT ON THE SDS. THERE WERE STENT STRUT IMPRESSIONS PRESENT ON THE SURFACE OF THE BALLOON BETWEEN THE MARKER BANDS, INDICATING THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THE BALLOON WAS IN A TIGHTLY FOLDED CONDITION WITH NO POSITIVE PRESSURE APPLIED AND MICROSCOPIC EXAMINATION OF THE BALLOON PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER/USE ERROR AS THE PHYSICIAN REPORTEDLY ATTEMPTED TO WITHDRAW THE UNDEPLOYED STENT BACK INTO THE GUIDE CATHETER AFTER ENCOUNTERING RESISTANCE. THE APPLICABLE DFU INCLUDES THE FOLLOWING CAUTIONS "IF UNUSUAL RESISTANCE IS FELT AT ANY TIME DURING LESION ACCESS BEFORE STENT IMPLANTATION, THE STENT SYSTEM AND THE GUIDE CATHETER SHOULD BE REMOVED AS A SINGLE UNIT UNDER DIRECT VISUALIZATION USING FLUOROSCOPY. DO NOT ATTEMPT TO PULL AN UNEXPANDED STENT BACK INTO THE GUIDING CATHETER WHILE ENGAGED IN THE CORONARY ARTERIES, AS STENT DAMAGE OR STENT DISLODGEMENT FROM THE BALLOON MAY OCCUR. APPLYING EXCESSIVE FORCE TO THE STENT SYSTEM CAN POTENTIALLY RESULT IN STENT OR COATING DAMAGE, STENT DISLODGEMENT FROM THE BALLOON, AND/OR DAMAGE TO THE DELIVERY SYSTEM." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE VASCULAR ACCESS SITE WAS THE RIGHT FEMORAL ARTERY. THE 80% STENOSED, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE LESION LENGTH WAS 30MM AND THE REFERENCE VESSEL DIAMETER WAS 2.5MM. A 6FR JR4 NON-BSC SH GUIDE CATHETER ALONG WITH A NON-BSC GUIDE WIRE WERE ADVANCED TO THE LESION. THE LESION WAS THEN PRE-DILATED WITH A 2.0X20MM BALLOON. NEXT A TAXUS LIBERTE' 2.5X32MM STENT WAS ADVANCED BUT THE STENT BECAME STUCK HALF IN THE GUIDE AND LESION ON THE INITIAL BEND IN THE RCA. THE STENT COULDN¿T BE ADVANCED FROM THAT LOCATION SO THE PHYSICIAN ATTEMPTED TO WITHDRAW THE STENT DELIVERY SYSTEM (SDS) BY PULLING HARD. THE GUIDE CATHETER, SDS AND GUIDE WIRE WERE REMOVED FROM THE PATIENT BUT THE STENT HAD DISLODGED FROM THE DELIVERY BALLOON. THE STENT COULD NOT BE LOCATED IN THE PATIENT THEREFORE NO ATTEMPT TO RETRIEVE THE STENT WAS MADE AND IT REMAINS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DILATING THE VESSEL AND THREE PROMUS 2.5X18MM STENTS WERE SUCCESSFULLY IMPLANTED. THE PATIENT HAS BEEN DISCHARGED AND NO FURTHER ACTION IS SCHEDULED TO RETRIEVE THE STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE VASCULAR ACCESS SITE WAS THE RIGHT FEMORAL ARTERY. THE 80% STENOSED, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE LESION LENGTH WAS 30MM AND THE REFERENCE VESSEL DIAMETER WAS 2.5MM. A 6FR JR4 NON-BSC SH GUIDE CATHETER ALONG WITH A NON-BSC GUIDE WIRE WERE ADVANCED TO THE LESION. THE LESION WAS THEN PRE-DILATED WITH A 2.0X20MM BALLOON. NEXT A TAXUS LIBERTE' 2.5X32MM STENT WAS ADVANCED BUT THE STENT BECAME STUCK HALF IN THE GUIDE AND LESION ON THE INITIAL BEND IN THE RCA. THE STENT COULDN'T BE ADVANCED FROM THAT LOCATION SO THE PHYSICIAN ATTEMPTED TO WITHDRAW THE STENT DELIVERY SYSTEM (SDS) BY PULLING HARD. THE GUIDE CATHETER, SDS AND GUIDE WIRE WERE REMOVED FROM THE PATIENT ,BUT THE STENT HAD DISLODGED FROM THE DELIVERY BALLOON. THE STENT COULD NOT BE LOCATED IN THE PATIENT THEREFORE, NO ATTEMPT TO RETRIEVE THE STENT WAS MADE AND IT REMAINS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DILATING THE VESSEL AND THREE PROMUS 2.5X18MM STENTS WERE SUCCESSFULLY IMPLANTED. THE PATIENT HAS BEEN DISCHARGED AND NO FURTHER ACTION IS SCHEDULED TO RETRIEVE THE STENT.

    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 - MAPLE GROVE H7493893632250 0013056257

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6FR JR4 LAUNCHER SH GUIDE CATHETER| PROWATER GUIDE WIRE