BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2071870 · Received April 28, 2011

    Report

    Report Number
    2134265-2011-01532
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 19, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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 THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT DEVELOPED A STENT THROMBOSIS. THE PATIENT PRESENTED INDEX PROCEDURE IN (B)(6) 2009 WITH AN ACUTE MYOCARDIAL INFARCTION AND AN UNKNOWN BARE METAL STENT WAS PLACED IN THE PROXIMAL LAD (LEFT ANTERIOR DESCENDING) ARTERY. IN (B)(6) 2009, DUE TO RESTENOSIS WITH TIMI II FLOW, PREDILATION WAS PERFORMED AND A 3.0X20MM (B)(4) STENT WAS PLACED AT 12ATM FOR 15 SECONDS WITH NO POST DILATION RESULTING IN 0% RESIDUAL STENOSIS AND TIMI III FLOW. THE PATIENT WAS DISCHARGED THE NEXT DAY. IN (B)(6) 2011, THE PATIENT WAS TO UNDERGO A HERNIA OPERATION. WHILE THE PATIENT WAS HOSPITALIZED, ANTIPLATELETS WERE TEMPORARILY STOPPED AND HEPARINE THERAPY WAS STARTED UNTIL THE PATIENT WAS TAKEN FOR SURGERY. WHILE HOSPITALIZED, THE PATIENT COMPLAINED OF CHEST PAIN AND ST ELEVATIONS WERE CONFIRMED. THE PHYSICIAN SUSPECTED A STENT THROMBOSIS, BUT THE PATIENT'S CHEST PAIN DISAPPEARED AND NO TREATMENT WAS PERFORMED. THE PATIENT AGAIN COMPLAINED OF CHEST PAIN IN (B)(6) 2009. A DE NOVO LESION IN THE LEFT MAIN CORONARY ARTERY TO HIGH LATERAL WAS DETECTED ON ELECTROCARDIOGRAM AND A THROMBOSIS-LIKE OCCLUSION WAS NOTED IN THE (B)(4) STENT IN THE PROXIMAL LAD. THROMBOSIS OF THE (B)(4) STENT WAS CONFIRMED BY CT AND WAS DIFFUSED WITH PLAVIX AND ASPIRIN.

    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 - GALWAY H7493893620300

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other