BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1883719 · Received October 27, 2010

    Report

    Report Number
    2134265-2010-04900
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    April 1, 2010
    Report Date
    October 6, 2010
    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

    DEVICE IS 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 #: 2134265-2010-04901, 2134265-2010-04902. 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 TO CARDIAC CATHETERIZATION. THE INDEX PROCEDURE TREATED THREE TARGET LESIONS. THE 1ST LESION WAS A 95% STENOSED, 2.5X16MM TARGET LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). TREATMENT CONSISTED OF PRE DILATION AND THE PLACEMENT OF A 2.5X20MM TAXUS LIBERTE STUDY STENT RESULTING IN 0% RESIDUAL STENOSIS. THE 2ND LESION WAS A 85% STENOSED, 3.0X16MM TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. TREATMENT UTILIZED A DIRECT STENT TECHNIQUE AND PLACED A 2.5X20MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE 3RD LESION WAS A 70% STENOSED, 3.0X12MM TARGET LESION LOCATED IN THE DISTAL LAD. TREATMENT UTILIZED A DIRECT STENT TECHNIQUE AND PLACED A 3.0X16MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. ONE DAY POST THE INDEX PROCEDURE, THE PATIENT EXPERIENCED ELEVATED ENZYMES CONSISTENT WITH THE PROTOCOL DEFINITION OF A MYOCARDIAL INFARCTION. NO ACTION WAS TAKEN TO TREAT THE EVENT WHICH RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED LATER THAT SAME DAY ON ASPIRIN AND PRASUGREL. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "UNRELATED" TO THE STUDY STENTS.

    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 37 YR Other 2.5X20 TAXUS LIBERTE STENT| 3.0X16 TAXUS LIBERTE STENT