BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1853095 · Received October 5, 2010

    Report

    Report Number
    2134265-2010-04338
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER-IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2010-04337. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, VESSEL PERFORATION AND PATIENT COMPLICATIONS OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. DIRECT STENTING WAS ATTEMPTED WITH A 4.0X12MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) BUT IT DID NOT CROSS THE LESION. A 3.0X6MM FLEXTOME CUTTING BALLOON WAS ADVANCED AND INFLATED TO 8ATMS/8SEC. THE PHYSICIAN RE-ADVANCED THE SAME 4.0X12 TAXUS LIBERTE SDS AND IT STILL DID NOT CROSS THE LESION. THE 3.0X6MM FLEXTOME CUTTING BALLOON WAS RE-ADVANCED AND INFLATED TO 8ATMS/6SEC. THE SAME 4.0X12MM TAXUS LIBERTE SDS WAS SUCCESSFULLY ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED AT 16ATMS/21SEC. AFTER DEPLOYMENT, FLUOROSCOPY SHOWED A VESSEL PERFORATION DISTAL TO THE STENT. THE PATIENT DEVELOPED CARDIAC TAMPONADE AND WENT INTO CARDIAC ARREST. CPR AND A DOPAMINE DRIP WERE INITIATED AND THE PATIENT WAS INTUBATED. A NON-BSC STENT WAS ADVANCED BUT COULD NOT CROSS THE LESION. A TAXUS LIBERTE 3.5X16MM WAS DEPLOYED DISTAL TO THE PERFORATION, OVERLAPPING THE 4.0X12MM TAXUS STENT. NEXT, A 4.0X12MM NON-BSC STENT WAS USED TO TREAT THE PERFORATION. THE PATIENT STABILIZED AND WAS TAKEN TO SURGERY FOR A PERICARDIAL WINDOW TO REMOVE THE FLUID ACCUMULATION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    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 H7493893612400 0013370148

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention FLEXTOME 3.0X6 CUTTING BALLOON| CORDIS WALLSTENT