BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2231635 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03647
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    October 9, 2007
    Report Date
    August 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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#: 2134265-2011-03621. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE STENT THROMBOSIS OCCURRED. IN (B)(6) 2004, THE PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN. ANGIOGRAPHY REVEALED 75-80% STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50X20MM TAXUS EXPRESS2 STENT WAS DEPLOYED IN THE MID LAD AND A 2.75X20MM TAXUS EXPRESS2 STENT WAS DEPLOYED, OVERLAPPING AND PROXIMAL TO THE FIRST PLACED STENT IN THE LAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS PUT ON PLAVIX. IN (B)(6) 2007, THE PATIENT PRESENTED WITH CHEST PAIN AND AN ACUTE MYOCARDIAL INFARCTION. ANGIOGRAPHY CONFIRMED THROMBOSIS IN THE PREVIOUSLY PLACED TAXUS EXPRESS2 STENTS IN THE LAD. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    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 Required Intervention 2.50X20MM TAXUS EXPRESS2 STENT