BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1673112 · Received May 4, 2010

    Report

    Report Number
    2134265-2010-02134
    Event Type
    Death
    Date Received
    May 4, 2010
    Date of Event
    February 5, 2010
    Report Date
    April 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). DEVICE EVALUATED BY MFR: 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

    (B) (4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED THE DE NOVO, 76% STENOSED, 3.24X21.2MM LESION OF THE PROXIMAL RCA (RIGHT CORONARY ARTERY). TREATMENT CONSISTED OF PREDILATION WITH A 2.5X15MM BALLOON, PLACEMENT OF A 3.5X32MM TAXUS EXPRESS2 STUDY STENT, AND POST DILATION WITH A 3.5X14MM BALLOON RESULTING IN A WELL-EXPANDED STENT WITH 18% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE WITH NO ANGINAL SYMPTOMS ON PLAVIX AND BAYASPIRIN. THE PATIENT EXPIRED IN (B) (4) 2010 AT ANOTHER FACILITY. THE CAUSE OF DEATH AND EVENTS LEADING UP TO THE PATIENT'S DEATH WERE NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493897032350 9460894

    Patients

    Seq Age Sex Outcome Treatment
    1 Death