BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1901756 · Received November 17, 2010

    Report

    Report Number
    2134265-2010-05030
    Event Type
    Injury
    Date Received
    November 17, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOS SANTOS ET AL. VERY LATE DRUG-ELUTING STENT THROMBOSIS POST-EXERCISE MYOCARDIAL PERFUSION SPECT. JOURNAL OF NUCLEAR CARDIOLOGY. VOLUME 17, NUMBER 5;928-33. (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT POST A STENTING TREATMENT PROCEDURE STENT THROMBOSIS OCCURRED. THE PATIENT PRESENTED WITH AN ANTERIOR NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. ANGIOGRAPHY SHOWED A 90% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). IT WAS NOTED THAT THERE WAS NO SIGNIFICANT DISEASE IN THE OTHER VESSELS. A BARE METAL STENT WAS DEPLOYED IN THE MID LAD AND ASPIRIN, CLOPIDOGREL, ATENOLOL AND SIMVASTATIN WERE PRESCRIBED. TEN MONTHS LATER THE PATIENT DEVELOPED SEVERE "INTRASTENT RESTENOSIS" IN THE PREVIOUSLY PLACED BARE METAL STENT AND A TAXUS STENT WAS SUCCESSFULLY IMPLANTED IN THE LESION. THE PATIENT WAS ASYMPTOMATIC THEREAFTER AND CLOPIDOGREL WAS DISCONTINUED AFTER 12 MONTHS OF TREATMENT. TWO YEARS AFTER THE TAXUS STENT WAS IMPLANTED, A TECHNETIUM-99M-SESTAMIBI STRESS-MYOCARDIAL PERFUSION SPECT SCAN SHOWED NO PERFUSION ABNORMALITIES. IMAGES SHOWED NORMAL VOLUMES WITH 66% LEFT VENTRICLE EJECTION FRACTION AND NO WALL MOTION ABNORMALITIES. AN UNSPECIFIED TIME LATER, THE PATIENT UNDERWENT A REST/STRESS STUDY, EXERCISING ON A BICYCLE FOR A TOTAL DURATION OF 8 MINUTES. APPROXIMATELY 40 MINUTES LATER THE PATIENT COMPLAINED OF MODERATE OPPRESSIVE CHEST PAIN. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT AND AN ECG SHOWED ST-SEGMENT ELEVATION IN ANTERIOR LEADS AS WELL AS ST-SEGMENT DEPRESSION IN INFERIOR LEADS. THE PATIENT WAS TAKEN FROM THE EMERGENCY DEPARTMENT TO THE CATH LAB AND ANGIOGRAPHY REVEALED A TOTALLY OCCLUDED LAD WITH INTRASTENT THROMBOSIS. A NON BSC STENT WAS SUCCESSFULLY IMPLANTED IN THE LESION AND THE PATIENT WAS DISCHARGED 5 DAYS LATER ON CLOPIDOGREL, ASPIRIN, ATORVASTATIN AND PERINDOPRIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention