BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2003925 · Received March 1, 2011

    Report

    Report Number
    2134265-2011-00408
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF THE TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) AND THE STENT IMPLANT. THE STENT WAS RECEIVED DETACHED FROM THE SDS. THERE WAS CONTRAST AND BLOOD VISIBLE ON THE SURFACES OF THE STENT IMPLANT. THE LENGTH OF THE STENT IMPLANT WAS CRUSHED AND STRETCHED. THE TIP OF THE SDS WAS DAMAGED. THE BALLOON WAS TIGHTLY FOLDED WITH CRIMP MARKS SHOWING EVIDENCE OF THE STENT SECUREMENT. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. MICROSCOPIC INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO FURTHER DAMAGE OR IRREGULARITIES. 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 CORONARY ARTERY STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN A SEVERELY CALCIFIED RCA (RIGHT CORONARY ARTERY). ROTATIONAL ATHERECTOMY WAS PERFORMED AND ONE ATTEMPT TO ADVANCE THE STENT DELIVERY SYSTEM WAS MADE. THE STENT DELIVERY SYSTEM WAS UNABLE TO ENTER THE LESION AND CAME OFF THE DELIVERY BALLOON. THE STENT WAS BLOCKED FROM MOVING DOWNSTREAM BY THE LESION AND WAS SNARED FOR REMOVAL FROM THE PATIENT. THE SNARE AND STENT WERE UNABLE TO FIT INTO THE GUIDE CATHETER SO THE GUIDE CATHETER AND SHEATH WERE REMOVED. THE SNARE AND STENT WERE THEN REMOVED FROM THE FEMORAL ARTERY CAUSING "MODERATE" BLEEDING FROM THE GROIN AREA. PRESSURE WAS HELD FOR AN "EXTENDED" PERIOD OF TIME. THE PROCEDURE WAS COMPLETED WITHOUT PLACEMENT OF A STENT. THE GROIN WAS CHECKED ONE DAY POST PROCEDURE AND FOUND TO BE NORMAL. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN A SEVERELY CALCIFIED RCA (RIGHT CORONARY ARTERY). ROTATIONAL ATHERECTOMY WAS PERFORMED AND ONE ATTEMPT TO ADVANCE THE STENT DELIVERY SYSTEM WAS MADE. THE STENT DELIVERY SYSTEM WAS UNABLE TO ENTER THE LESION AND CAME OFF THE DELIVERY BALLOON. THE STENT WAS BLOCKED FROM MOVING DOWNSTREAM BY THE LESION AND WAS SNARED FOR REMOVAL FROM THE PATIENT. THE SNARE AND STENT WERE UNABLE TO FIT INTO THE GUIDE CATHETER SO THE GUIDE CATHETER AND SHEATH WERE REMOVED. THE SNARE AND STENT WERE THEN REMOVED FROM THE FEMORAL ARTERY CAUSING "MODERATE" BLEEDING FROM THE GROIN AREA. PRESSURE WAS HELD FOR AN "EXTENDED" PERIOD OF TIME. THE PROCEDURE WAS COMPLETED WITHOUT PLACEMENT OF A STENT. THE GROIN WAS CHECKED ONE DAY POST PROCEDURE AND FOUND TO BE NORMAL. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS OKAY.

    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 H7493893624400 13139306

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention