BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL ELUTING STENT

    MDR report key: 753773 · Received August 18, 2006

    Report

    Report Number
    6000093-2006-01562
    Event Type
    Death
    Date Received
    August 18, 2006
    Date of Event
    August 8, 2005
    Report Date
    July 25, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. AS THE BATCH NUMBER FOR THIS COMPLAINT IS UNKNOWN, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CAUSE OF THE DIFFICULTIES EXPERIENCED COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SAME AS CASE MFR#6000093-2006-01563. CLINICAL STUDY. IT WAS REPORTED THAT 122 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE PATIENT HAS A HISTORY OF PREVIOUS UNKNOWN TYPE STENT PLACEMENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE PROXIMAL FIRST OBTUSE MARGINAL (OM) IN 2001. IN 2005, THE PATIENT UNDERWENT STENT PLACEMENT TO THE PROXIMAL AND DISTAL CIRCUMFLEX (CX) ARTERY. BOTH LESIONS WERE PRE-DILATED. A TAXUS EXPRESS2 3.00 X12MM STENT WAS PLACED IN THE OSTIUM OF THE PROXIMAL CX AND A TAXUS EXPRESS2 3.00X20MM STENT WAS PLACED IN THE DISTAL CX. BOTH STENTS WERE POSTED DILATED. DURING THE PROCEDURE ANGIOMAX WAS ADMINISTERED AND FOLLOWING THE PROCEDURE, THE PATIENT WAS GIVEN 300MG OF PLAVIX. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND PLAVIX. PER THE AUTOPSY REPORT, IT WAS REPORTED THAT 122 DAYS FOLLOWING THE PROCEDURE, THE PATIENT CAME TO AN OUTPATIENT GASTROENTEROLOGY SUITE FOR A COLONOSCOPY. THE PATIENT HAD BEEN ADVISED BY HIS CARDIOLOGIST TO DISCONTINUE PLAVIX AND ASPIRIN IN PREPARATION FOR THE COLONOSCOPY. FOLLOWING A SUCCESSFUL PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE RECOVERY AREA. APPROXIMATELY 15 MINUTES LATER, THE PATIENT COMPLAINED OF LOWER CHEST AND ABDOMINAL PAIN. THE PATIENT HAD LOW BLOOD PRESSURE AND BRADYCARDIA. THE PATIENT UNDERWENT GENERALIZED CARDIOPULMONARY ARREST. THE PATIENT WAS IN VENTRICULAR FIBRILLATION AND WAS NOT RESPONSIVE TO DRUGS AND MULTIPLE SHOCKS. DESPITE RESUSCITATIVE EFFORTS, THE PATIENT WAS PRONOUNCED DEAD. THE AUTOPSY REPORT STATED THAT THE RIGHT CORONARY ARTERY (RCA) WAS 90% STENOSED, THE CX WAS 75-80% STENOSED, AND THE LAD HAD CLOT/THROMBUS IN THE STENTED AREA. THE AUTOPSY CONCLUDED THAT THE CAUSE OF DEATH WAS AN ACUTE MYOCARDIAL INFARCTION WITH AN OCCLUSIVE THROMBUS OF THE LAD STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 3.00X12MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death