BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1930836 · Received December 16, 2010

    Report

    Report Number
    2134265-2010-05588
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) CLINICAL STUDY. SAME CASE AS MFR REPORT #: 2134265-2010-05587, 2134265-2010-05589. IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE INDEX PROCEDURE TREATED THREE TARGET LESIONS. THE 1ST LESION WAS A 90% STENOSED, 2.75X20MM TARGET LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. TREATMENT UTILIZED A DIRECT STENT TECHNIQUE AND PLACED A 2.75X32MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS FOLLOWING POST DILATION. THE 2ND LESION WAS A 70% STENOSED, 3.0X5MM TARGET LESION LOCATED IN THE PROXIMAL LCX ARTERY. TREATMENT UTILIZED A DIRECT STENT TECHNIQUE AND PLACED A 3.0X12MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE 3RD LESION WAS A 75% STENOSED, 3.0X10MM TARGET LESION LOCATED IN THE RAMUS ARTERY. TREATMENT UTILIZED A DIRECT STENT TECHNIQUE AND PLACED A 3.0X20MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. LATER THAT DAY, POST THE INDEX PROCEDURE THE PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES RESULTING IN A MYOCARDIAL INFARCTION. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "PROBABLY RELATED" 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 H7493893612300 13363162

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other 2.75X32 TAXUS LIBERTE STENT| 3X20 TAXUS LIBERTE STENT