BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1020313 · Received March 26, 2008

    Report

    Report Number
    2134265-2008-00868
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 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 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 #2134265-2008-00869. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN, AND TESTS REVEALED A LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD). THERE WAS A 75% STENOSIS IN THE PROXIMAL LAD AND A 90% STENOSIS IN THE MID LAD. THE PROXIMAL LAD WAS 3.0MM IN DIAMETER AND THE MID LAD WAS 2.75MM IN DIAMETER. THE LESION IN THE PROXIMAL LAD WAS 10MM IN LENGTH AND THE LESION IN THE MID LAD WAS 15MM IN LENGTH. THE PATIENT WAS DIAGNOSED WITH NON-ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS GIVEN 300MG OF CLOPIDOGREL AND AN INFUSION OF 400 UNITS/HOUR OF HEPARIN WERE STARTED. THE PHYSICIAN DEPLOYED A 2.75X24MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE MID LAD AT 16 ATMS, AND THEN A 3.00X20MM TAXUS EXPRESS2 STENT WAS DEPLOYED IN THE PROXIMAL LAD AT 16 ATMS, OVERLAPPING THE 2.75X24MM TAXUS STENT. THE PHYSICIAN UTILIZED THE KISSING BALLOON TECHNIQUE IN THE LAD AND THE 1ST DIAGONAL USING A NON-BSC BALLOON AND AN UNSPECIFIED BALLOON (UNKNOWN SIZES). IVUS REVEALED THE STENT WAS DILATED WELL AND THERE WERE NO PATIENT COMPLICATIONS. THE TOTAL AMOUNT OF HEPARIN USED DURING THE PROCEDURE WAS 5000U. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE CARDIAC CARE UNIT BECAUSE THE PATIENT'S CONDITION WAS UNSTABLE. AN INFUSION OF 400 UNITS/HOUR OF HEPARIN WAS RESTARTED POST-PROCEDURE. TWO DAYS LATER, THE PATIENT WAS TRANSFERRED TO THE GENERAL WARD. ONE DAY LATER, THE PATIENT REPORTED CHEST PAIN IN THE GENERAL WARD. TESTS DETECTED ST ELEVATION, AND A THROMBUS WAS OBSERVED IN THE PROXIMAL TO MID LAD WHERE THE TWO TAXUS STENTS WERE OVERLAPPING. INTRA AORTIC BALLOON PUMP (IABP) WAS INSERTED, THE THROMBUS WAS ASPIRATED AND THEN DILATED WITH AN UNKNOWN SIZE NON-BSC BALLOON. IVUS REVEALED NO ABNORMAL FINDING WITH THE PATIENT. FOUR DAYS LATER, THE PATIENT'S CONDITION WAS IMPROVED AN IABP WAS WITHDRAWN. THE PATIENT REMAINS HOSPITALIZED TO FOLLOW HIS PROGRESS. THE PATIENT WAS NOT RESISTANT TO ANTIPLATELET MEDICATION, AND THE RELATIONSHIP BETWEEN THE TAXUS STENTS AND THE THROMBOSIS EVENT IS UNKNOWN.

    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 3.00X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention NC SPRINTER BALLOON