BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1111583 · Received August 13, 2008

    Report

    Report Number
    2134265-2008-02323
    Event Type
    Death
    Date Received
    August 13, 2008
    Date of Event
    April 24, 2008
    Report Date
    July 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT: 2134265-2008-02320, -02321, -02322. TAXUS EXPRESS2 POST MARKET SURVEILLANCE STUDY, IT WAS REPORTED THAT 13 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE IDENTIFIED AND TREATED TWO TARGET LESIONS. TARGET LESION ONE WAS A DE NOVO, 100% STENOSED LESION OF THE MID RCA (RIGHT CORONARY ARTERY) MEASURING 3.5X60MM. TARGET LESION ONE WAS TREATED WITH PREDILATION USING TWO 2.5X15MM BALLOON CATHETERS AND PLACEMENT OF THREE TAXUS EXPRESS2 DRUG ELUTING STENTS (3.5X24MM, 3.0X28MM, AND 2.5X12MM). POST-IVUS (INTRAVASCULAR ULTRASOUND) SHOWED THE STENTS WERE WELL POSITIONED AND WELL APPOSED WITH 0% RESIDUAL STENOSIS. TARGET LESION TWO WAS A DE NOVO, 90% STENOSED LESION OF THE L-AV (LEFT ATRIOVENTRICULAR) MEASURING 2.5X22MM. TARGET LESION TWO WAS TREATED WITH A PREDILATION USING A 2.5X15MM BALLOON AND PLACEMENT OF A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT. POST-IVUS SHOWED THE STENTS WERE WELL POSITIONED AND WELL APPOSED WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED FIVE DAYS POST PROCEDURE ON BAYASPIRIN AND PANALDINE. THE PATIENT PRESENTED TO THE HOSPITAL 13 DAYS POST PROCEDURE IN CARDIAC AND RESPIRATORY ARREST AND WAS PRONOUNCED DEAD. ACCORDING TO THE PATIENT'S FAMILY, THERE WAS A POSSIBILITY THAT THE PATIENT DID NOT TAKE THE ANTIPLATELET AGENTS PROPERLY AFTER DISCHARGE FROM THE HOSPITAL. THE INVESTIGATOR ASSESSED THE RELATIONSHIP OF THE DEVICES TO THE EVENT AS POSSIBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ - STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 2.5X24MM 9427952

    Patients

    Seq Age Sex Outcome Treatment
    1 Death