BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY SYSTEM

    MDR report key: 617507 · Received June 24, 2005

    Report

    Report Number
    6000089-2005-00964
    Event Type
    Death
    Date Received
    June 24, 2005
    Date of Event
    January 16, 2005
    Report Date
    May 25, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 316 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PATIENT EXPERIENCED AN MI THAT LED TO THE PATIENT DEATH. THE PATIENT WAS INITIALLY TREATED WITH A DRIVER STENT TO THE MIDPOINT OF THE SVG TO RCA. THEN A DRIVER STENT TO THE MIDPORTION OF THE SVG TO RCA. THEN A DRIVER STENT WAS PLACED IN THE MIDPOINT OF THE SVG TO OM1. TARGET LESION 1 (16MM LONG) WAS IDENTIFIED IN THE OSTIAL/PROXIMAL PORTION OF THE SVG TO OM1 WITH 75% STENOSIS AND A 4.5 MM REFERENCE VESSEL DIAMETER. TARGET LESION 1 TREATMENT WAS INITIALLY ATTEMPTED WITH A 3.5 X 16 STENT (ASSUMED TO BE A TAXUS STENT, BUT NOT SPECIFIED IN THE CATH REPORT). THERE WAS A GUIDE DISSECTION OF HTE OSTIUM OF THE SVG TO OM1, AND IT WAS DECIDED TO PLACE A 3.5X24 MM (LOT 6170391) TAXUS STENT. RESIDUAL STENOSIS WAS 0% FOLLOWING POST-DILATION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ONE DAY POST INDEX PROCEDURE RECEIVING ASA, PLAVIX, AND LIPOR. THE SITE REPORTED THAT THE PATIENT DIED AT HOME IN THIER SLEEP 316 DAYS POST INDEX PROCEDURE. THE DEATH CERTIFICATE NOTES THE IMMEDIATE CAUSE OF DEATH AS `ACUTE MYOCARDIAL INFARCTION'. THERE WAS NO AUTOPSY PERFORMED AND NO FURTHER INFORMATION IS AVAILABLE. IN THE OPINION OF THE PHYSICIAN THERE IS AN UNKNOWN RELATIONSHIP BETWEEN THE EVENTS AND THE TARGET VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 3.50 X 24 MM 6170391

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death