BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1045246 · Received May 14, 2008

    Report

    Report Number
    2134265-2008-01374
    Event Type
    Death
    Date Received
    May 14, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE MFR#2134265-2008-01375. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, ACUTE MYOCARDIAL INFARCTION, STENT THROMBOSIS, AND DEATH OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) AND DISTAL LEFT CIRCUMFLEX (LCX) TO THE LEFT POSTEROLATERAL (LPL). THE LESION IN THE DISTAL LCX TO LPL WAS 90% STENOSED, 12-13MM IN LENGTH, AND 2.5MM IN DIAMETER. THE LESION CHARACTERISTICS OF THE LAD WERE UNK. THE LESIONS WERE CALCIFIED AND TORTUOUS. THE PT PRESENTED WITH ANGINA PECTORIS. THE PHYSICIAN PREDILATED THE TARGET LESION WITH AN UNSPECIFIED TYPE/SIZE BALLOON AT 14 ATMS. THE PHYSICIAN THEN IMPLANTED THE 2.50X16MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE DISTAL LCX TO LPL. NEXT, THE PHYSICIAN IMPLANTED THE 2.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE LAD. THE LESION WAS POSTDILATED AT 18ATMS. INTRAVASCULAR (IVUS) ULTRASOUND REVEALED NO ABNORMAL FINDINGS IN THE MID LAD. THE PHYSICIAN ATTEMPTED TO USE IVUS ON THE DISTAL LCX TO LPL, BUT WAS UNABLE TO CROSS THE LESION. CORONARY ANGIOGRAPHY REVEALED THAT A PORTION OF THE 2.50X16MM TAXUS STENT WAS NOT DILATED COMPLETELY, BUT TIMI 3 WAS OBTAINED. THE PT WAS LATER DISCHARGED AT AN UNSPECIFIED DATE. AT 125 DAYS LATER, THE PT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION WHICH CAUSED A STROKE. THE PT WAS TRANSPORTED TO ANOTHER HOSPITAL BY AMBULANCE. CORONARY ANGIOGRAPHY REVEALED A COMPLETE TOTAL OCCLUSION INSIDE THE 2.50X16MM TAXUS STENT IN THE DISTAL LCX TO LPL. THROMBOTIC ASPIRATION WAS PERFORMED AND RED THROMBUS WAS REMOVED. HOWEVER, PERIPHERAL BLOOD FLOW WAS NOT IMPROVED, SO PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED WITH AN UNSPECIFIED SIZE/TYPE BALLOON. BLOOD FLOW INDICATED TIMI 1, SO AN UNK SIZE NON-BSC BARE METAL STENT WAS IMPLANTED IN THE DISTAL PORTION OF THE 2.50X16MM TAXUS STENT, AND THE 2.50X16MM TAXUS STENT WAS DILATED WITH AN UNK SIZE BALLOON. NEXT, THE PHYSICIAN IMPLANTED AN UNK SIZE LIBERTE BARE METAL STENT IN THE PROXIMAL PORTION OF THE 2.50X16MM TAXUS STENT, BUT BLOOD FLOW WAS NOT IMPROVED COMPLETELY. THE PT SUFFERED SEVERE HEMODYNAMIC DETERIORATION AND DIED LATER ON THE SAME DAY. THE OFFICIAL CAUSE OF DEATH IS LISTED AS ACUTE MYOCARDIAL INFARCTION. MEDICATIONS TAKEN BY THE PT INCLUDED NITROGLYCERINE, SIGMART, HEPARIN, PANALDINE, AND ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 2.50X20MM 9725974

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| R