BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2165533 · Received July 17, 2011

    Report

    Report Number
    2134265-2011-02974
    Event Type
    Injury
    Date Received
    July 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE - YANG EH, PEREZ E, ZHIROFF KA, BURSTEIN SM. LEFT MAIN STENT THROMBOSIS COMPLICATED BY EPTIFIBATIDE-INDUCED ACUTE THROMBOCYTOPENIA. TEX HEART INST J. 2011; 38(2): 174-8. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH THROMBOSIS. THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH AN ANTERIOR ST-ELEVATION MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION REVEALED AN ACUTELY OCCLUDED AND THROMBOSED LEFT MAIN CORONARY ARTERY. AFTER A FAILED THROMBECTOMY, A 3.5X24MM TAXUS LIBERTE STENT WAS SUCCESSFULLY DEPLOYED. PERIPROCEDURALLY, THE PATIENT RECEIVED ASPIRIN, CLOPIDOGREL, UNFRACTIONATED HEPARIN, AND EPTIFIBATIDE. THE PATIENT HAD MULTI VESSEL DISEASE AND WAS SCHEDULED TO UNDERGO OUTPATIENT STRESS TESTING AND IF INDICATED, A STAGED PCI. THE PATIENT WAS DISCHARGED ON DAY 7, BUT RETURNED LATER THE SAME DAY TO THE EMERGENCY ROOM WITH RECURRENCE OF SEVERE CHEST PAIN AND ST ELEVATIONS IN THE ANTERIOR LEADS. REPEAT CARDIAC CATHETERIZATION REVEALED PROXIMAL ACUTE THROMBOSIS OF THE 3.5X24MM TAXUS LIBERTE STENT IMPLANTED IN THE LEFT MAIN CORONARY ARTERY. THE PATIENT UNDERWENT REPEAT STENTING WITH A 3.5X12MM LIBERTE STENT AND RECEIVED READMINISTRATION OF EPTIFIBATIDE. ON THE NEXT DAY, THE PATIENT'S PLATELET COUNT DROPPED ACUTELY TO LESS THAN 12,000/MM3. A TEST FOR HEPARIN-INDUCED THROMBOCYTOPENIA ANTIBODY WAS NEGATIVE. IT WAS CONCLUDED THAT THE RE-EXPOSURE TO EPTIFIBATIDE WAS THE PROBABLE CAUSE OF THE ACUTE THROMBOCYTOPENIA. AFTER DISCONTINUATION OF EPTIFIBATIDE, THE PATIENT'S PLATELET COUNT GRADUALLY RETURNED TO NORMAL, AND THE PATIENT WAS LATER DISCHARGED ON DAY 12 OF READMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention