BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1945095 · Received January 3, 2011

    Report

    Report Number
    2134265-2010-05814
    Event Type
    Death
    Date Received
    January 3, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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 REPORT #:2134265-2010-05813, 2134265-2010-05662. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, ACUTE THROMBOSIS AND DEATH OCCURRED. TWO LESIONS WERE IDENTIFIED AT A BIFURCATION. A 90% STENOSED DE NOVO TYPE C LESION MEASURING 2.5-3MM IN DIAMETER AND 40MM IN LENGTH WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) TO A NON-CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD); THE SECOND LESION WAS A 90% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) TO OBTUSE MARGINAL ARTERY (OM). PRE-PROCEDURE TIMI FLOW WAS NOTED TO BE 0. IVUS WAS PERFORMED AND A 3.0X32MM TAXUS LIBERTE' STENT WAS DEPLOYED AT 15 ATMS IN THE MID LAD. THE LCX TO OM LESION WAS PREDILATED WITH A 3.0X15MM NON BSC BALLOON. A 3.0X32MM TAXUS LIBERTE' STENT WAS DEPLOYED AT 15 ATMS IN THE SECOND LESION. A PT2 GUIDE WIRE WAS PASSED THROUGH THE STENT STRUTS INTO THE LAD, AND BOTH A 2.0X12 MAVERICK2 BALLOON AND A 3.0X15MM NON BSC BALLOON WERE INFLATED. A 3.5X20MM TAXUS LIBERTE' STENT WAS DEPLOYED AT 18 ATMS IN THE LMCA TO LAD, OVERLAPPING WITH THE 3.0X32MM TAXUS LIBERTE' STENT THAT WAS IMPLANTED IN THE MID LAD. A 3.5X20MM MAVERICK2 BALLOON WAS INSERTED IN THE LMCA TO LAD AND A 3.0X20MM MAVERICK2 BALLOON WAS INSERTED INTO THE LMCA TO LCX, AND A KISSING BALLOON TECHNIQUE WAS PREFORMED TO POST-DILATE THE LESIONS. IVUS CONFIRMED THE STENTS WERE WELL POSITIONED AND WELL OPPOSED. THE PROCEDURE WAS COMPLETED WITH 0% RESIDUAL STENOSIS AND TIMI FLOW OF III. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAD BEEN TAKING 100MG ASPIRIN AND 75MG CLOPIDOGREL PER DAY FOR APPROXIMATELY 6 WEEKS PRIOR TO THE PROCEDURE AND CONTINUED WITH ANTIPLATELET THERAPY POST PROCEDURE. LATER THE SAME DAY, THE PATIENT HAD A DECREASE IN BLOOD PRESSURE AND WENT INTO SHOCK. THROMBOSIS WAS CONFIRMED IN THE 3.5X20MM TAXUS LIBERTE' STENT THAT WAS IMPLANTED IN THE LMCA TO LAD. AN INTRA-AORTIC BALLOON PUMP WAS INSERTED, A THROMBECTOMY CATHETER WAS USED TO REMOVE THE THROMBUS AND BALLOON ANGIOPLASTY WAS PERFORMED. THE PATIENT DID NOT RECOVER AND EXPIRED THAT DAY.

    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 H7493893632300 13554751

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death LS PT2 GUIDE WIRE| LS WHISPER WIRE| 7FR MACH Q4 GUIDE CATHETER| 3.0X15MM LACROSS BALLOON| 3.5X20MM TAXUS LIBERTE' STENT| 3.0X20MM MAVERICK2 BALLOON| 3.5X20MM MAVERICK2 BALLOON| 3.0X32MM TAXUS LIBERTE' STENT| 2.0X12MM MAVERICK2 BALLOON