BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 759876 · Received September 8, 2006

    Report

    Report Number
    6000093-2006-01785
    Event Type
    Death
    Date Received
    September 8, 2006
    Date of Event
    August 5, 2006
    Report Date
    August 10, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SOURCE CONFIRMED THAT THE PRODUCT HAD BEEN DISPOSED AND NO ANALYSIS WAS POSSIBLE. THE REPORTED BATCH NUMBER 8317644 WAS REWORKED FROM TOP ASSEMBLY BATCH NUMBER 8172859. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BACTH 8172859 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE DIFFICULITIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL TRIAL. SAME CASE AS MFR# 6000089-2006-01960, -01959, AND 6000093-2006-01784. IT WAS REPORTED THAT 137 DAYS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED 4 LESIONS. LESION 1 WAS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN DIRECT STENTED THE LESION WITH A 3.5 X 16 MM TAXUS EXPRESS2 STENT. LESIONS 2 AND 3 WERE IN THE DISTAL CIRCUMFLEX (CX). THE PHYSICIAN DIRECT STENTED THE LESION WITH A 3.0 X 28 MM AND A 2.5 X 20 MM TAXUS EXPRESS2 STENTS. THE STENTS DID NOT OVERLAP. LESION 4 WAS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS TOTALLY OCCLUDED. THIS WAS A BIFURCATED LESION WITH THE FIRST DIAGONAL, BUT THE PHYSICIAN CHOSE NOT TO TREAT THE FIRST DIAGONAL PORTION. THE PHYSICIAN THEN DIRECT STENTED THE LESION WITH A 3.5 X 16 MM TAXUS EXPRESS2 STENT. THERE WAS NO SEVERE CALCIFICATION OR TORTUOUSITY IN ANY OF THE LESIONS. THE PATIENT RECEIVED HEPARIN, ABCIXIMAB, AND NITRATES DURING THE PROCEDURE. RESIDUAL STENOSIS WAS LESS THAN 30% IN ALL LESIONS POST INDEX PROCEDURE. POST PROCEDURALLY, THE PATIENT DID EXPERIENCE ELEVATED TROPONIN LABS. THIS RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND PLAVIX. AROUND DAY 130, THE PATIENT REPORTEDLY EXPERIENCED PERITONITIS. THE PATIENT ALSO EXPERIENCED PURULENT BRONCHITIS AND A PERFORATION OF A SIGMOID DIVERTICULA. THE PATIENT EXPIRED ON DAY 137; CAUSE OF DEATH FROM AUTOPSY LISTED AS SEPTIC SHOCK DUE TO PURULENT AND FIRINEUS PERITONITIS. IN THE OPINION OF THE PHYSICIAN, INDEX PROCEDURE OR STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.5 X 16 MM 8172859

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death