BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 2020704 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00669
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    October 5, 2010
    Report Date
    February 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU (B)(4).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT AND OTHER RELEVANT HISTORY UPDATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AT THE TIME OF THE INDEX PROCEDURE PCI WAS PERFORMED IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE RESTENOTIC TARGET LESION LOCATED IN THE PROX RCA WITH REFERENCE VESSEL DIAMETER OF 3.20 MM, A LENGTH OF 26.9 MM WAS TREATED WITH PRE-DILATATION, DEPLOYMENT OF A 3.00X32 MM TAXUS EXPRESS 2 STENT AND POST-DILATATION. RESIDUAL STENOSIS BECAME 7%. TIMI-3 FLOW REMAINED UNCHANGED THROUGHOUT THE PROCEDURE. THE LESION LOCATED IN THE PROXIMAL LAD WAS TREATED WITH DEPLOYMENT OF A NON BSC STENT. IN (B)(6) 2008, THE PATIENT WAS DIAGNOSED WITH SILENT ISCHEMIA AND WAS DISCHARGED ON BAYASPIRIN, PLAVIX AND WARFARIN.

    Description of Event or Problem · 1

    (B)(6). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPIRED. THE LESION BEING TREATED WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE PHYSICIAN SUCCESSFULLY IMPLANTED A 3.00X32MM TAXUS EXPRESS2 STENT IN THE LESION. IN (B)(6) 2010, THE PATIENT EXPIRED. THE PHYSICIAN HEARD THIS INFORMATION FROM OTHER FACILITY, THEREFORE THE CAUSE OF THE DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897032300

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death