BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1832642 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-04218
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT.(B)(4).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

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT EMBOLIZATION OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY WITH A 6F RUNWAY KRH GUIDE CATHETER AND ANOTHER MANUFACTURER'S GUIDE WIRE. THE LESION BEING TREATED WAS "TIGHT" AND LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RCA (RIGHT CORONARY ARTERY). THE LESION WAS PREDILATED WITH UNSPECIFIED 2.0X12MM AND 2.25X12MM BALLOONS. DURING DEPLOYMENT, THE STENT "WATERMELON-SEEDED" OUT OF THE VESSEL AND WHEN THE DELIVERY BALLOON WAS DEFLATED THE STENT EMBOLIZED INTO THE AORTA. ATTEMPTS TO LOCATE THE STENT WERE UNSUCCESSFUL AND IT WAS NOT RETRIEVED. FOLLOWING THIS EVENT, THE CASE WAS STOPPED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS LISTED AS OKAY.

    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 H7493893616220 13517182

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2.25X12MM BALLOON| 6F RUNWAY KRH GUIDE CATHETER| PILOT 50 GUIDE WIRE| 2.0X12MM BALLOON