BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2093805 · Received May 18, 2011

    Report

    Report Number
    2134265-2011-01703
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    June 11, 2010
    Report Date
    April 19, 2011
    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

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. THE PATIENT INITIALLY PRESENTED DUE TO A MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION REVEALED 3 TARGET LESIONS WHICH WERE TREATED DURING TWO SEPARATE PROCEDURES. (B)(6) - 2010: A 90% STENOSED AND 26MM LONG TARGET LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.8MM WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.5X32MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND PRASUGREL. (B)(6) - 2010: DURING A STAGED PROCEDURE, A SECOND TARGET LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH A 3.0X12MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. A THIRD TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). IT WAS TREATED WITH A 2.75X24MM TAXUS LIBERTE STENT. A DISTAL EDGE DISSECTION OCCURRED IN THE LAD POST STENT PLACEMENT. THIS WAS TREATED WITH A 2.5X8MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. ONE DAY LATER, THE PATIENT EXPERIENCED CARDIAC ENZYME ELEVATION INDICATING A MYOCARDIAL INFARCTION HAD OCCURRED (PEAK TROPONIN= 11.75 NG/ML, ULN=0.03 NG/ML). NO ACTION WAS TAKEN TO TREAT THIS AND THE EVENT WAS REPORTED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    SAME PATIENT AS MFR #S 2134265-2012-00790, 2134265-2012-00621, AND 2134265-2012-00895. IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED AT THE TIME OF THE INDEX PROCEDURE DUE TO AN ST ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY WAS 90% STENOSED AND 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS 70% STENOSED AND 20M LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.75X24MM TAXUS LIBERTE STENT. AT THE TIME THE POST PROCEDURAL MYOCARDIAL INFARCTION OCCURRED, THERE WERE NO ISCHEMIC SYMPTOMS. AN ECG SUGGESTED A NON-Q-WAVE MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893624270 0013377031

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention