BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1210712 · Received October 23, 2008

    Report

    Report Number
    2134265-2008-03114
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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: 2134265-2008-03115. IT WAS REPORTED THAT FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, VESSEL DISSECTION AND THROMBOSIS OCCURRED. AN UNK SIZE TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE 80% STENOSED LESION LOCATED IN THE MILDLY CALCIFIED, MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). AN UNK SIZE TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE 80% STENOSED LESION LOCATED IN THE NON-CALCIFIED, NON-TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (RCA). THE STENTS WERE WELL APPOSED. FOUR HOURS POST THE INITIAL INTERVENTION, THE PT PRESENTED WITH CHEST PAIN. THE DISTAL STENT HAD CAUSED A DISSECTION RESULTING IN A THROMBOSIS. THE PHYSICIAN RESTENTED WITH A PROMUS STENT AND THE PT TOLERATED THIS WELL. PT STATUS REPORTED AS "OK".

    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 Required Intervention