BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 648961 · Received December 1, 2005

    Report

    Report Number
    6000093-2005-01364
    Event Type
    Death
    Date Received
    December 1, 2005
    Date of Event
    July 3, 2005
    Report Date
    November 1, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE OSTIUM OF A SAPHENOUS VEIN GRAFT AND WAS 6MM LONG. THE LESION WITH DIRECT STENTING USING A FILTER WIRE EZ DISTAL PROTECTION DEVICE, REDUCING THE STENOSIS TO 0% FOLLOWING STENT PLACEMENT. A 40% LESION IN THE MID PORTION OF THE SAPHENOUS VEIN GRAFT WAS NOT COVERED BY THE STENT. 62 DAYS AFTER THE INITIAL PROCEDURE, THE PATIENT WAS ADMITTED WITH INCREASED CONFUSION, DECREASED ALERTNESS, AND POOR APPETITE. THE PT HAD RECENTLY BEEN TREATED WITH IV FLUID REPLACEMENT FOR DEHYDRATION AND BACTRIM THERAPY FOR A URINARY TRACT INFECTION (DATES UNKNOWN). THE ADMISSION PLACE INCLUDED A DIETARY CONSULTATION, IV FLUID REPLACEMENT, AND NUTRITIONAL SUPPLIEMENTS. A CHEST X-RAY (DATE UNKNOWN) SHOWED BILATERAL PLEURAL EFFUSIONS; RESULTS OF A GI SERIES (DATE UNKNOWN) FOR POSSIBLE ABDOMINAL OBSTRUCTION ARE NOT AVAILABLE. THE PATIENT EXPIRED 11 DAYS LATER. COMPLICATIONS THROUGHOUT THE HOSPITALIZATION INCLUDED DEMENTIA, CHRONIC RENAL INSUFFICIENCY, HYPERTENSION, AND URINARY TRACT INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 74 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THAT PATIENT EXPIRED. THE LESION BEING TREATED IN THE INDEX PROCEDURE WAS A 4.0MM, 90% STENOSED PREVIOUSLY BYPASSED PORTION OF THE DISTAL LEFT ANTERIOR DESCENDING (DIST LAD) ARTERY. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENTING AND SUCCESSFULLY PLACING A TAXUS EXPRESS 8.8% 3.50X16MM DRUG ELUTING STENT IN THE TARGET LESION. THERE WERE NO COMPLICATIONS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON PLAVIX AND ASPIRIN. 74 DAYS AFTER THE INITIAL PROCEDURE IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE WAS NO AUTOPSY. THE CAUSE OF DEATH WAS STATED AS FAILURE TO THRIVE. IN THE OPINION OF THE PHYSICIAN THE TARGET VESSEL WAS NOT INVOLVED.

    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 CORP. TAXUS EXPRESS2 8.8% 3.50 X 16 MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death