BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2170474 · Received July 21, 2011

    Report

    Report Number
    2134265-2011-02797
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    January 24, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(6). 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

    (B)(6). SAME CASE AS MFR ID#: 2134265-2011-02992, 2134265-2011-02993. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION OCCURRED. THE PATIENT PRESENTED AT THE TIME OF THE INDEX PROCEDURE DUE TO RECURRENT ANGINA. CARDIAC CATHETERIZATION REVEALED 3 TARGET LESIONS. THE FIRST WAS A 95% STENOSED AND 26MM LONG LESION LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA) WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THIS WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25X24MM TAXUS LIBERTE STENT. POST DILATION WAS ATTEMPTED WITH A 2.75X20MM QUANTUM BALLOON BUT IT WAS UNABLE TO CROSS SO POST DILATION WAS PERFORMED WITH A QUANTUM APEX BALLOON RESULTING IN 0% RESIDUAL STENOSIS. THE SECOND WAS A 90% STENOSED AND 5MM LONG LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. A 3.5X8MM QUANTUM BALLOON WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. PREDILATION WAS PERFORMED WITH A QUANTUM APEX BALLOON AND A 2.75X12MM TAXUS LIBERTE STENT WAS DEPLOYED FOLLOWED BY POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. THE THIRD WAS A 60% STENOSED AND 20MM LONG LESION LOCATED IN THE MID RCA WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THIS WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.5X24MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS. FOLLOWING FINAL STENT PLACEMENT, THE PATIENT DEVELOPED SEVERE INTERMITTENT CHEST PAIN WITH INFERIOR ST SEGMENT ELEVATION. THIS WAS TREATED MEDICALLY AND THE PATIENT WAS PAIN FREE AFTER THE PROCEDURE. CARDIAC ENZYMES WERE FOUND TO BE ELEVATED AND THE PATIENT WAS DIAGNOSED AS HAVING A MYOCARDIAL INFARCTION. THIS EVENT IS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND PRASUGREL. IT IS THE OPINION OF THE PHYSICIAN THAT THIS EVENT IS NOT RELATED TO THE TAXUS LIBERTE 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 H7493893624220 13448441

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention