BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1832188 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-03919
    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).

    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

    IT WAS FURTHER REPORTED THAT THIS 3.5X12MM TAXUS LIBERTE STENT WAS USED AS TREATMENT FOR THE DISSECTION AND DID NOT CONTRIBUTE TO THE DISSECTION AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2010-03917. 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 H7493893612350 0013010197

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention