BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 689173 · Received March 15, 2006

    Report

    Report Number
    6000089-2006-00390
    Event Type
    Death
    Date Received
    March 15, 2006
    Date of Event
    October 29, 2005
    Report Date
    February 13, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY: SAME CASE AS A00015443-000, A00015445-000 AND A00015446-000. IT WAS REPORTED THAT 18 MONTHS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PATIENT EXPIRED. LESION 1 WAS A 2.8MM, 95% STENOSED PORTION OF THE 1ST OBTUSE MARGINAL ARTERY. THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS2 8.8% 2.75X8MM DRUG ELUTING STENT IN THE TARGET LESION. LESION 2 WAS A 2.7MM, 90% STENOSED PORTION OF THE RAMUS. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT OF TWO TAXUS EXPRESS2 8.8% DRUG ELUTING STENTS IN THE TARGET LESION. A 2.50X12MM WAS PLACED FIRST. THIS STENT SLIPPED AND THE 2.5X8MM WAS PLACED WITH A 1.0MM OVERLAP TO COVER THE LESION. LESION 3 WAS A 2.6MM, 95% STENOSED PORTION OF THE RAMUS. 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. THERE WERE NO REPORTED COMPLICATIONS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON PLAVIX AND ASPIRIN. 18 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT EXPIRED. THERE WAS NO AUTOPSY AND IN THE OPINION OF THE PHYSICIAN THE CAUSE OF DEATH WAS CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND THE TARGET VESSEL WAS NOT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC 2.50X8MM 6090737

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death
    2 *
    3 *