BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 622762 · Received July 25, 2005

    Report

    Report Number
    6000093-2005-00865
    Event Type
    Death
    Date Received
    July 25, 2005
    Date of Event
    June 24, 2005
    Report Date
    June 30, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT RESIDUAL STENOSIS WAS 0% AFTER TAXUS STENT IMPLANTATION. ANGIOPLASTY TO THE OSTIUM OF THE DIAGONAL WAS ALSO PERFORMED WITH 50% RESIDUAL STENOSIS. THE SITE LEARNED THAT THE PT WAS HOSPITALIZED 19 DAYS POST INDEX PROCEDURE BUT NO DOCUMENTS ARE AVAILABLE FROM THAT HOSPITALIZATION. PER INVESTIGATOR SUMMARY, THE PT DIED W HILE PARTICIPATING IN THE TELEPHONE FOLLOW UP STAGE OF THE STUDY. THE DEATH CERTIFICATE STATES THAT THE DEATH DATE WAS 32 DAYS POST INDEX PROCEDURE AND THE CAUSE OF DEATH WAS SEPTIC SHOCK. "IT APPEAR FROM THE TIMING OF THE EVENT THAT IT IS UNLIKELY RELATED TO THE TAXUS STENT OR STUDY PROCEDURES" (PER INVESTIGATOR SUMMARY). NO AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    CLINICAL STUDY #152-035. IT WAS REPORTED THAT 32 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED ONE TARGET LESION. TARGET LESION 1 WAS A 2.5 MM VESSEL DIAMETER, 70% STENOSED REGION OF THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS 7.0 MM LONG AND HAD MILD CALCIFICATION. THE PHYSICIAN DIRECT STENTED THE LESION WITH ONE TAXUS EXPRESS2 8.8% 2.5X20 MM (LOT 7213134) DRUG ELUTING STENT WITHOUT COMPLICATION. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON DAY POST INDEX PROCEDURE RECEIVING ASA AND PLAVIX. THE SITE REPORTED THAT THE PATIENT EXPIRED DUE TO RESPIRATORY FAILURE 32 DAYS POST INDEX PROCEDURE. IN THE OPINION OF THE PHYSICIAN THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE TARGET VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 2.50 X 20 MM 7213134

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death