BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1219549 · Received October 31, 2008

    Report

    Report Number
    2134265-2008-04162
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT # 213265-2008-04161. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. THE PRIMARY DISEASE WAS OLD MYOCARDIAL INFARCTION. THE 90% STENOSED AND MODERATELY CALCIFIED AND TORTUOUS TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT WAS 3.5MM IN DIAMETER. WHILE ATTEMPTING TO CROSS THE LESION WITH A 3.0X16MM TAXUS EXPRESS2 DRUG ELUTING STENT , DIFFICULTY OCCURRED. SEVERAL ATTEMPTS TO CROSS THE LESION WERE MADE BUT WERE UNSUCCESSFUL. UPON REMOVAL IT WAS NOTED THAT A STENT STRUT LIFTED. THE PHYSICIAN CHANGED TO A NEW DEVICE, ANOTHER 3.0X16MM TAXUS EXPRESS2 DRUG ELUTING STENT, AND AGAIN SEVERAL ATTEMPTS WERE MADE TO CROSS THE LESION UNSUCCESSFULLY. IT WAS REPORTED THAT EVENTUALLY A STENT STRUT LIFTED UP ON THE SECOND DEVICE AS WELL. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN DEVICE WITH NO INJURIES BEING REPORTED TO THE PATIENT.

    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 CORPORATION 3.00X16MM 11779303

    Patients

    Seq Age Sex Outcome Treatment
    1