BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904464 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05211
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    July 2, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    (B)(4). SAME CASE AS MFR REPORT #: 2134265-2010-05208, 2134265-2010-05209, 2134265-2010-05210. IT WAS REPORTED THAT FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE TREATED 4 LESIONS. THE FIRST TARGET LESION WAS A 99% STENOSED, 2.7X20MM TARGET LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). TREATMENT CONSISTED OF PRE-DILATION, THE PLACEMENT OF A 2.75X24MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE SECOND TARGET LESION WAS A 95% STENOSED 3.5X12MM LESION LOCATED IN THE MID RCA. TREATMENT CONSISTED OF PRE-DILATION, THE PLACEMENT OF A 3.5X16MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE THIRD TARGET LESION WAS A 75% STENOSED, 2.7X12MM LESION LOCATED IN THE 1ST DIAGONAL BRANCH. TREATMENT CONSISTED OF PRE-DILATION, THE PLACEMENT OF A 2.75X16MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE FOURTH TARGET LESION WAS A 95% STENOSED 3.0X15MM LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. TREATMENT CONSISTED OF PRE-DILATION, THE PLACEMENT OF A 3.0X24MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. ONE DAY POST THE INDEX PROCEDURE, CARDIAC ENZYME ELEVATION WAS CONSISTENT WITH A MYOCARDIAL INFARCTION. NO ACTION WAS TAKEN AND THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    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 H7493893624300 13022156

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other 2.75X16MM TAXUS LIBERTE STENT| 2.75X24MM TAXUS LIBERTE STENT| 3.5X16MM TAXUS LIBERTE STENT