BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL ELUTING CORONARY STENT

    MDR report key: 704032 · Received April 24, 2006

    Report

    Report Number
    6000093-2006-00695
    Event Type
    Death
    Date Received
    April 24, 2006
    Date of Event
    February 11, 2006
    Report Date
    March 29, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ARRIVE 2 CLINICAL STUDY 128 DAYS POST INDEX PROCEDURE, THE PT EXPIRED. THE INDEX PROCEDURE TREATED ONE TARGET LESION. TARGET LESION 1 WAS LOCATED IN A SAPHENOUS VEIN GRAFT TO THE R-PDA WITH 90% STENOSIS. THE LESION WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5. TARGET LESION 1 WAS TREATED WITH DIRECT PLACEMENT OF A 3.5 X 16MM TAXUS STENT. RESIDUAL STENOSIS WAS 0% AFTER DEPLOYMENT. EMBOLIC PROTECTION WAS USED. THE PT WAS DISCHARGED FROM THE HOSP 1 DAY POST INDEX PROCEDURE RECEIVING ASPIRIN AND PLAVIX. PER TELEPHONE CONTACT WITH THE PT'S DAUGHTER, THE PT WAS ADMITTED TO A NON-ENROLLING HOSP WITH CONGESTIVE HEART FAILURE (DATE UNK) AND EXPIRED ON DAY 128. CAUSE OF DEATH PER ECRF IS "CONGESTIVE HEART FAILURE". IN THE OPINION OF THE PHYSICIAN, IT IS UNK IF THERE WAS A RELATIONSHIP BETWEEN THE TAXUS STENT AND THE DEATH. IT IS NOT KNOWN WHETHER OR NOT AN AUTOPSY WAS PERFORMED, AND NO OTHER INFO IS AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.50 X 16MM 7752840

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death