BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1022603 · Received April 1, 2008

    Report

    Report Number
    2134265-2008-00923
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS 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 MFR# 2134265-2008-00922. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, VESSEL DISSECTION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS CALCIFIED, 90% STENOSED, AND MODERATELY TORTUOUS. THE LESION WAS PREDILATED WITH A 2.25MM NON-BSC BALLOON AT 12 ATMS. THE PHYSICIAN THEN IMPLANTED A 3.50X16MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE PROXIMAL LAD. NEXT, TWO 2.50X24MM TAXUS EXPRESS2 DRUG ELUTING STENTS WERE IMPLANTED IN THE MID TO DISTAL LAD. DURING POSTDILATATION WITH ONE OF THE 2.50X24MM STENT BALLOONS, (IT IS UNK WHICH DEVICE), DISSECTION OCCURRED DISTAL TO THE STENTED VESSEL. IT WAS REPORTED THAT THE "DISTAL EDGE OF THE 2.50X24MM STENT MIGHT BE EXPANDED EXCESSIVELY." THE PHYSICIAN TREATED THE DISSECTION WITH A 2.50X12MM TAXUS EXPRESS2 DRUG ELUTING STENT. THERE WERE NO PT SYMPTOMS REPORTED AT THE TIME OF THE EVENT AND THE PT CONDITION IS REPORTED AS GOOD. NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DURG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 2.50X24MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INFLATION DEVICE: ENCORE| GUIDE CATHETER: AXESS 6F JL 3.5| GUIDE WIRE: ROUTE| BALLOON: MERCURY 2.25MM