BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 729781 · Received June 26, 2006

    Report

    Report Number
    6000093-2006-01155
    Event Type
    Death
    Date Received
    June 26, 2006
    Date of Event
    October 17, 2005
    Report Date
    June 14, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINTANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFO BECOMES AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ARRIVE CLINICAL TRIAL #050-040. IT WAS REPORTED THAT 555 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE PT EXPIRED, DUE TO UNK CAUSES. THE PT PRESENTED TO THE E.R. IN 2004 AFTER A RECENT FALL. AT THE TIME OF ADMISSION, THE PT REPORTED A "FEW MONTHS" OF ANGINA AND THE PT WAS NOTED TO BE MILDLY CONFUSED AND COMPLAINING OF A HEADACHE. ON ADMISISON, ECG REVEALED ATRIAL FIBRILLATION WITH A RAPID VENTRICULAR RESPONSE AND EVOLUTION OF A NON-TRANSMURAL MI WITH T-WAVES BECOMING DEEPLY INVERTED IN THE PRE-CORDIAL LEADS. CARDIAC ENZYMES WERE NOTED TO BE "HIGH". A CT SCAN OF THE BRAIN WAS NEGATIVE FOR HEMORRHAGIC STROKE. HEPARIN AND CARDIZEM WERE ADMINISTERED. CORONARY ANGIOGRAPHY 7 DAYS FOLLOWING ADMISSION REVEALED: RCA - OCCLUDED; LCX - NO RE-NARROWING OF THE PREVIOUSLY DILATED OM BRANCH; LIMA TO LAD - PATENT; AND SVG TO OM1 - PATENT WITH 70% DISTAL NARROWING. THE INDEX PROCEDURE WAS PERFORMED 10 DAYS POST-ADMISSION AND IDENTIFIED 1 TARGET LESION. TARGET LESION 1 WAS 3.5X8MM, 80% STENOSED, MODERATELY TORTUOUS, DE NOVO LESION LOCATED IN THE SVG TO OM1. TARGET LESION 1 WAS DIRECT STENTED AT 12ATM WITH THIS 3.0X16MM TAXUS EXPRESS2 STENT AND POST-DILATED AT 12ATM. THERE WAS 0% RESIDUAL STENOSIS. THERE WAS NO EVIDENCE OF DISSECTION OR EMBOLIZATION. DUE TO THE PT'S GENERAL STRENGTH, IT WAS FELT THAT HE WAS NOT READY FOR DISCHARGE HOME. THE PT UNDERWENT PHYSICAL THERAPY AND WAS DISCHARGED 14 DAYS FOLLOWING THE INDEX PROCEDURE IN STABLE CONDITION TO A CONVALESCENT CENTER ON ASPIRIN AND PLAVIX. THE SITE DISCOVERED THAT THE PT EXPIRED 555 DAYS FOLLOWING THE INDEX PROCEDURE FROM A SOCIAL SECURITY DEATH INDEX WEB SEARCH. THE CAUSE OF DEATH IS UNK AND NO AUTOPSY WAS PERFORMED. THE RELATIONSHIP OF THE DEVICE TO THIS EVENT IS UNK.

    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. 3.00X16MM 6182603

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death