BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1963034 · Received January 18, 2011

    Report

    Report Number
    2134265-2010-05945
    Event Type
    Injury
    Date Received
    January 18, 2011
    Report Date
    December 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AHN CM, HONG BK, KIM JY ET AL. INCIDENCE AND NATURAL HISTORY OF CORONARY ARTERY ANEURYSM DEVELOPING AFTER DRUG-ELUTING STENT IMPLANTATION. AMERICAN HEART JOURNAL 2010;160(5):987-994. DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION, VERY LATE STENT THROMBOSIS AND A CORONARY ARTERY ANEURYSM OCCURRED. THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION WITH NO ST ELEVATIONS. THE GREATER THAN 70% STENOSED TYPE C LESION WAS LOCATED IN A RIGHT CORONARY ARTERY THAT HAD A VESSEL DIAMETER EQUAL TO OR GREATER THAN 2.5MM. A TAXUS EXPRESS2 STENT OF UNKNOWN SIZE WAS IMPLANTED IN THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS PLACED ON CLOPIDOGREL AND ASPIRIN. APPROXIMATELY 106 DAYS LATER, THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION WITH NO ST ELEVATIONS, VERY LATE STENT THROMBOSIS AND A CORONARY ARTERY ANEURYSM OF MULTIPLE SACCULAR MORPHOLOGY. THE ANEURYSM WAS IDENTIFIED DURING EMERGENT FOLLOW-UP ANGIOGRAPHY. THE PATIENT WAS MEDICALLY MANAGED. IT WAS ALSO NOTED THAT THE PATIENT WAS COMPLIANT WITH ANTIPLATELET THERAPY AT THE TIME OF THE EVENT.

    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 - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention