BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2002990 · Received February 28, 2011

    Report

    Report Number
    2134265-2011-00567
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    December 24, 2006
    Report Date
    January 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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

    SAME CASE AS MFR. ID#: 2134265-2011-00566. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. AT THE INDEX PROCEDURE, THE PATIENT HAD AN UNKNOWN SIZE TAXUS EXPRESS2 STENT IMPLANTED IN THE POSTERIOR DESCENDING CORONARY ARTERY AND AN UNKNOWN SIZE TAXUS EXPRESS2 STENT IMPLANTED IN THE OBTUSE MARGINAL CORONARY ARTERY. (B)(6) 2006, THE PATIENT EXPERIENCED STENT THROMBOSIS THAT REQUIRED MEDICAL INTERVENTION. THROMBOSIS WAS IDENTIFIED IN THE TWO PREVIOUSLY PLACED TAXUS EXPRESS2 STENTS IN ADDITION TO A THIRD NON BSC DRUG ELUTING STENT THAT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY.

    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 Hospitalization| R TAXUS EXPRESS2 STENT