BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1445146 · Received August 19, 2009

    Report

    Report Number
    2134265-2009-04035
    Event Type
    Death
    Date Received
    August 19, 2009
    Date of Event
    May 5, 2009
    Report Date
    July 21, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS 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. LITERATURE CITATION: UNPROTECTED LEFT MAIN STENTING IN THE REAL WORLD: TWO-YEAR OUTCOMES OF THE FRENCH LEFT MAIN TAXUS REGISTRY. CIRCULATION 2009; 119(17): 2349-56. VAQUERIZO B, LEFEVRE T, DARREMONT O, SILVESTRI M, LOUVARD Y, LEYMARIE JL, ET AL.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL ARTICLE TITLED, "UNPROTECTED LEFT MAIN STENTING IN THE REAL WORLD: TWO-YEAR OUTCOMES OF THE FRENCH LEFT MAIN TAXUS REGISTRY" THAT TEN MONTHS POST CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, RESTENOSIS AND PT DEATH OCCURRED. THE LESION, LOCATED IN THE UNPROTECTED LEFT MAIN (LM) ARTERY, WAS STENTED WITH AN UNSPECIFIED TAXUS EXPRESS2 DRUG ELUTING STENT. TEN MONTHS POST PROCEDURE, THE PT PRESENTED WITH LEFT ANTERIOR DESCENDING (LAD) ARTERY RESTENOSIS. DURING PERCUTANEOUS INTERVENTION, AN EMBOLIZATION OCCURRED AND THE PT DIED. NO FURTHER INFO IS AVAILABLE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death