BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT

    MDR report key: 689000 · Received March 15, 2006

    Report

    Report Number
    6000089-2006-00393
    Event Type
    Death
    Date Received
    March 15, 2006
    Date of Event
    August 12, 2005
    Report Date
    February 15, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY : SAME CASE AS 600093-2006-00391,600093-2006-00392. IT WAS REPORTED THAT 246 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PATIENT EXPIRED. TARGET LESION 1 SAS A 2.5MM, 90% STENOSED PORTION OF THE DISTAL RIGHT CORONARY ARTERY (DIST RCA). THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS2 8.8% 2.50X16MM DRUG ELUTING STENT IN THE TARGET LESION. LESION 2 WAS A 2.5MM, 90% STENOSED PORTION OF THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). THE PHYSICIAN TREATED THE LESSION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS3 8.8% 2.50X16MM DRUG ELUTING STENT IN THE TARGET LESION. LESION 3 WAS A 2.5MM, 95% STENOSED PORTION OF THE 1ST OBTUSE MARGINAL (1ST OB MARG). THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS2 8.8% 2.50X8MM DRUG ELUTING STENT IN THE TARGET LESION. THERE WERE NO COMPLICATIONS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON PLAVIX AND ASPIRIN. 246 DAYS AFTER THE INITIAL PROCEDURE, THE PATIENT EXPIRED. THERE WAS NO AUTOPSY, IN THE OPINION OF THE PHYSICIAN THE CAUSE OF DEATH WAS CARDIAC ARREST, CONGESTIBE HEART FAILURE AND CARDIOMYOPATHY. THE RELATIONSHIP OF DEATH TO THE TARGET VESSEL IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 2.50X8MM 7080223

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death