BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 798354 · Received December 20, 2006

    Report

    Report Number
    6000089-2006-02601
    Event Type
    Death
    Date Received
    December 20, 2006
    Date of Event
    November 23, 2006
    Report Date
    November 23, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW THEREFORE A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8253536 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. THIS PARTICULAR BATCH NUMBER 8253536 HAS NO ASSOCIATED COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 85 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, A PATIENT DEATH OCCURRED. THE PATIENT INITIALLY PRESENTED WITH POLYMORPHIC VENTRICULAR TACHYCARDIA. ANGIOGRAPY REVEALED A 95% LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) AND AN 80% LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT'S LAD ANATOMY WAS MILDLY TORTUOUS, THE VESSEL WAS NOT CALCIFIED AND THE LESION WAS A TYPE B2. THE LAD WAS PRE-DILATED WITH AN UNSPECIFIED SIZE BALLOON AND A TAXUS EXPRESS2 2.50X16MM DRUG ELUTING STENT (DES) WAS DEPLOYED IN THE DISTAL LAD. THE STENT WAS NOT POST-DILATED, APPEARED WELL APPOSED AND RESIDUAL STENOSIS WAS REPORTED TO BE LESS THAN 10%. SEVERAL DAYS LATER A NON-BSC DES WAS DEPLOYED IN THE MID LAD. APPROXIMATELY 85 DAYS LATER THE PATIENT PRESENTED WITH CHEST PAIN. ANGIOGRAPHY REVEALED THAT BOTH STENTS IN THE LAD WERE PATENT. TWO WEEKS LATER THE PATIENT PRESENTED WITH "VENTRICULAR FIBRILLATION ARREST" AT HER HOME. THE PATIENT WAS "DOWN FOR AT LEAST 10 MINUTES BEFORE EMS SHOCKED HER." THE PATIENT WAS TRANSFERRED TO THE HOSPITAL. ANGIOGRAPHY REVEALED THE NON-BSC DES WAS PATENT BUT THE TAXUS STENT IN THE DISTAL LAD WAS OCCLUDED. THE AREA OF OCCLUSION WAS TREATED WITH ANGIOPLASTY AND TWO UNSPECIFIED BARE METAL STENTS WERE PLACED IN THE DISTAL LAD. SEVERAL DAYS LATER THE PATIENT WAS DEEMED BRAIN DEAD AFTER PROLONGED "VFIB ARREST" AND "PROLONGED ANOXIA." THE PHYSICIAN REPORTED THAT "AS FAR AS WE KNOW, THE PATIENT WAS ON PLAVIX AND ASPIRIN DURING THE ENTIRE TIME." THE PHYSICIAN'S OPINION IS THAT THE EVENT IS RELATED TO THE STENT.

    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 2.50X16MM 8253536

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death CORDIS CYPHER DES (SIZE UNSPECIFIED)