BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 2840947 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07108
    Event Type
    Death
    Date Received
    November 20, 2012
    Date of Event
    January 3, 2012
    Report Date
    October 26, 2012
    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

    DEVICE IS A COMBINATION PRODUCT. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME PATIENT AS MFR REPORT #: 2134265-2009-06082. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (MID RCA) WITH 90% STENOSIS AND WAS 24MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION USING A 2.5MM BALLOON AT 12ATMS AND PLACEMENT OF A 3.50X24MM TAXUS EXPRESS2 STENT. A NON-BSC STENT WAS PLACED IN THE INFERIOR SEPTAL BRANCH. THE PATIENT WAS DISCHARGED ON PANALDINE 200MG AND BAYASPIRIN 100MG. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT CONDITION WAS GOOD. IN (B)(6) 2012, THE PATIENT'S FAMILY REPORTED THAT THE PATIENT EXPIRED. THE SITE WAS UNABLE TO OBTAIN DETAILED INFORMATION TO MAKE A MEDICAL DECISION FROM THE PATIENT'S FAMILY. AT THE TIME OF THE EVENT, THE PATIENT'S ANTIPLATELET THERAPY WAS BAYASPIRIN 100MG AND PANALDINE 200MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493897024350 9666641

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death CYPHER STENT