BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1881050 · Received October 25, 2010

    Report

    Report Number
    2134265-2010-04675
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2010-04674, 2134265-2010-04780 AND 2134265-2010-04781. IT WAS REPORTED THAT AFTER A STENTING TREATMENT PROCEDURE, THROMBOSIS AND PATIENT COMPLICATIONS OCCURRED. ACCESS WAS OBTAINED THROUGH THE RIGHT RADIAL ARTERY. THE TARGET LESIONS WERE LOCATED IN THE DIAGONAL, LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE RIGHT CORONARY ARTERY (RCA). A NON-BSC GUIDE CATHETER WAS ADVANCED AND A KINETIX GUIDEWIRE CROSSED THE LESION IN THE FIRST DIAGONAL. THE DIAGONAL WAS PREDILATED WITH A 2.0X12MM APEX BALLOON INFLATED TO 12ATMS/31SECONDS. IVUS WAS PERFORMED WITH A NON-BSC CATHETER AND THEN THE APEX BALLOON WAS READVANCED TO DILATE THE OSTIAL DIAGONAL AT 16ATMS/12SECONDS. A 2.5X28MM NON-BSC STENT WAS DEPLOYED IN THE DIAGONAL AT 14ATMS/42SEC. NEXT THE LAD WAS TREATED. A 2.0X15MM APEX BALLOON WAS ADVANCED TO THE DISTAL LAD AND INFLATED TO 6ATMS/20SEC AND 10ATMS/19SEC. AFTER IVUS WAS PERFORMED WITH THE NON-BSC CATHETER, A 2.25X32MM TAXUS LIBERTE ATOM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE DISTAL LAD AND THE STENT WAS DEPLOYED AT 8ATMS/40SEC. A 2.25X12MM TAXUS LIBERTE ATOM SDS WAS ADVANCED TO THE DISTAL LAD AND DEPLOYED AT 16ATMS/39SEC. THE DELIVERY BALLOON WAS INFLATED TO 10ATMS/13SEC TO POST DILATE THE STENT. AFTER EXCHANGING THE GUIDE CATHETER FOR ANOTHER NON-BSC GUIDE CATHETER, THE KINETIX GUIDE WIRE WAS ADVANCED TO THE RCA. A 2.0X15MM APEX BALLOON WAS ADVANCED AND INFLATED TO 8ATMS/12SEC AND 10ATMS/12SEC TO PREDILATE THE LESION. NEXT, A 2.25X28 TAXUS LIBERTE ATOM SDS WAS ADVANCED AND THE STENT WAS DEPLOYED IN THE MID RCA AT 16ATMS/50SEC. THE DELIVERY BALLOON WAS INFLATED TO 12ATMS/12SEC IN THE PROXIMAL RCA. A 2.5X16MM TAXUS LIBERTE SDS WAS ADVANCED TO THE PROXIMAL RCA AND DEPLOYED AT 145ATMS/11SEC. THE STENT WAS POST DILATED WITH A 2.5X12MM APEX BALLOON INFLATED TO 10ATMS/16SEC. SHORTLY AFTER THE CASE ENDED, THE PATIENT STARTED VOMITING, WAS DIAPHORETIC AND ST ELEVATIONS WERE NOTED. IT WAS NOTED A THROMBOSIS WAS OCCURRING. A NON-BSC SHEATH WAS INSERTED IN THE RIGHT GROIN AND IMMEDIATE ARTERIAL BLEEDING OCCURRED. ACCESS WAS OBTAINED AT THE RIGHT FEMORAL ARTERY. INTEGRILIN WAS ADMINISTERED AND AN INTRA-AORTIC BALLOON PUMP WAS PLACED. A HEPARIN AND NITROGLYCERIN DRIP WAS STARTED AND THE PATIENT WENT TO RECOVERY IN STABLE CONDITION. THE NEXT DAY THE PATIENT HAD A REPEAT ANGIOGRAPHY AND THE CLOT HAD DISSIPATED.

    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 H7493893612220

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R 2.5X15MM APEX BALLOON| 014X185 KINETIX GUIDEWIRE| 2.0X15MM APEX BALLOON| 2.25X32MM TAXUS LIBERTE ATOM| 2.5X16MM TAXUS LIBERTE| 2.5X12MM APEX BALLOON| 2.9X150 VOLCANO EAGLE EYE GOLD IVUS| 6F BARBEAU GUIDE CATHETER| 2.5X28MM XIENCE STENT| 2.0X12MM APEX BALLOON| 2.25X28 TAXUS LIBERTE ATOM| 6F XB 3.5 GUIDE CATHETER