BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1912011 · Received December 1, 2010

    Report

    Report Number
    2134265-2010-05163
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. IF IMPLANTED, GIVE DATE: (B)(6) 2009. 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 CORONARY STENTING TREATMENT PROCEDURE, VERY LATE STENT THROMBOSIS AND A MYOCARDIAL INFARCTION WITHOUT ST ELEVATIONS OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE LESION WAS LOCATED AT THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY AND THE SECOND DIAGONAL ARTERY. THE LESION WAS PREDILATED WITH A 2.5X12MM NON BSC BALLOON AT 8 ATMS FOR 12 SECONDS. A 2.25X16MM TAXUS EXPRESS2 STENT WAS DEPLOYED AT 13 ATMS FOR 14 SECONDS. NO PATIENT INJURIES WERE REPORTED. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PLAVIX. NINETEEN MONTHS LATER THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION WITHOUT ST ELEVATIONS, ELEVATED TROPONIN AND VERY LATE IN-STENT THROMBOSIS. THE PATIENT HAD NOT BEEN TAKING ANTIPLATELET THERAPY FOR 2-3 MONTHS PRIOR TO THE THROMBOSIS. A 2.5X18MM NON BSC STENT WAS PLACED TO TREAT THE THROMBOSIS. THE STENT WAS POST-DILATED WITH A 2.5MM NC QUANTUM BALLOON. NO FURTHER PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS LISTED AS OKAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    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 H7493897016220 12017418

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 2.5X12 VOYAGER BALLOON