BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1051071 · Received May 22, 2008

    Report

    Report Number
    2134265-2008-01493
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 5, 2007
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030028
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2008-001495, 2134265-2008-01496. IT WAS REPORTED BY THE PT THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, HEART ATTACK, "CLOGGED UP" STENTS, AND A 5 WAY BYPASS OCCURRED. AFTER HAVING A HEART ATTACK, THREE UNK SIZE TAXUS EXPRESS2 DRUG ELUTING STENTS WERE DEPLOYED IN AN UNSPECIFIED VESSEL. TWO YEARS POST THE INITIAL PROCEDURE, THE PT HAD ANOTHER HEART ATTACK. THREE OR FOUR DAYS LATER, THE PT RECEIVED A 5 WAY BYPASS "SINCE ALL HIS ARTERIES AND STENTS WERE CLOGGED UP". ADDITIONAL INFO WAS REQUESTED, BUT NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention