BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1832246 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-03917
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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: 2134265-2010-03919. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED DISSECTION. THE TARGET LESION BEING TREATED WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS 100% STENOSED, 2.5MM IN DIAMETER AND 28 MM LONG. THE TARGET LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.25X32MM AND 3.5X12MM TAXUS LIBERTE STENT. DURING THE PROCEDURE, A DISSECTION OCCURRED. A 3.0X16MM TAXUS LIBERTE BAILOUT STENT WAS USED TO TREAT THE DISSECTION. RESIDUAL STENOSIS WAS 0%. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 2 DAYS LATER 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 H7493893632250 0013058359

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention