BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1012357 · Received February 12, 2008

    Report

    Report Number
    2134265-2008-00740
    Event Type
    Death
    Date Received
    February 12, 2008
    Date of Event
    February 16, 2008
    Report Date
    February 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2008-00741, 2134265-2008-00742, 2134265-2008-00743. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS, STENT THROMBOSIS, MYOCARDIAL INFARCTION, CHEST PAIN, AND PATIENT DEATH OCCURRED. THE PT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION AND A 100% STENOSIS WAS FOUND AT THE LCX. THE PHYSICIAN IMPLANTED A 3.50X32MM TAXUS EXPRESS2 DRUG ELUTING STENT. ONE HUNDRED SEVENTY THREE DAYS LATER, FOLLOW UP WAS DONE WITH CORONARY ANGIOGRAPHY, AND THROMBOSIS WAS CONFIRMED WITH IN-STENT RESTENOSIS AT THE PROXIMAL TO DISTAL LCX. IN-STENT RESTENOSIS WAS FOUND WITHIN THE 3.50X32MM TAXUS EXPRESS2 STENT (70% STENOSIS). THE LESIONS BEING TREATED WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) AND IN THE LEFT CIRCUMFLEX (LCX) ARTERIES. THE PROXIMAL LAD WAS 3.5MM IN A DIAMETER WITH A 70% STENOSIS AND A 1.5MM LENGTH LESION. THE LCX WAS 2.5MM IN DIAMETER WITH A 70% STENOSIS AND A 3.5M LENGTH LESION. BOTH LESIONS WERE CALCIFIED AND BOTH VESSELS WERE TORTUOUS. ONE DAY LATER, THE PHYSICIAN WAS UNABLE TO PASS THE INTRAVASCULAR ULTRASOUND (IVUS) THROUGH THE PROXIMAL TO DISTAL LCX. THE PHYSICIAN PREDILATED THE PROXIMAL TO DISTAL LCX WITH AN APEX 2.50X20MM BALLOON AT 12 ATMS FOR 30 SECONDS AND 16 ATMS FOR 15 SECONDS. A GUIDEWIRE WAS INSERTED TO THE PROXIMAL LAD AND THE LESION WAS PREDILATED WITH A 2.50X20MM APEX BALLOON AT 16 ATMS. A 3.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS IMPLANTED AT THE PROXIMAL LAD AT 10 ATMS AND WAS POST DILATED WITH THE DELIVERY BALLOON. THE PROXIMAL LCX WAS THEN PREDILATED WITH A 2.50X20MM APEX BALLOON AT 12 ATMS, AND A 2.50X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS IMPLANTED AT THE PROXIMAL TO DISTAL LCX, AND THEN A 2.50 X 16MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS IMPLANTED WITH BOTH STENTS OVERLAPPING THE PREVIOUSLY PLACED STENTS. IT WAS POST DILATED WITH THE DELIVERY BALLOON. THE FLOW WAS CONFIRMED WITH ANGIOGRAPHY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. TWO DAYS LATER, THE PT COMPLAINED OF CHEST PAIN. OVER THE NEXT 6 HRS, THE PT WAS PLACED ON INTRANASAL 3L AND 5L MEDICATION AND HEPARIN. THE PT EXPERIENCED DEPRESSED CONSCIOUSNESS AND HEART MASSAGE WAS DONE. PERCUTANEOUS CARDIOPULMONARY BYPASS SUPPORT (PCPS) WAS INSERTED. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE MID LAD AND THE PROXIMAL LCX. BOTH VESSELS WERE DILATED WITH A 2.5X15MM MAVERICK2 BALLOON, BUT FLOW COULD NOT BE RESTORED. THE PT WITH PCPS WAS TAKEN TO THE ICU WITH A HEART RATE OF 50-60. SUBSEQUENTLY, THE PT DIED. THE PHYSICIAN FELT THE PRIMARY CAUSE OF DEATH WAS AMI FOR ISR WITH TWO LESIONS. THE RELATIONSHIP BETWEEN THE TAXUS STENTS AND THE THROMBOSIS IS UNKNOWN. THE PT WAS REPORTED TO BE COMPLAINT WITH ANTIPLATELET THERAPY (TICLOPIDINE AND ASPIRIN TAKEN SINCE 2007).

    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 3.50X32MM

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| R