BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1844356 · Received September 24, 2010

    Report

    Report Number
    2134265-2010-04270
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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 STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE HIGH GRADE STENOSED LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). A GUIDE CATHETER WAS INSERTED AND A CHOICE PT GUIDE WIRE WAS PLACED ACROSS THE LESION. A 2.75X8MM LIBERTE' BARE METAL STENT WAS ADVANCED TO THE LESION, BUT COULD NOT CROSS. THE PHYSICIAN ATTEMPTED TO PULL THE DEVICE BACK INTO THE GUIDE CATHETER, BUT WAS UNABLE TO WITHDRAW THE STENT. THE GUIDE CATHETER, GUIDE WIRE AND LIBERTE" BARE METAL STENT WERE REMOVED TOGETHER. WHILE REMOVING THE DEVICES, THE STENT DISLODGED AND WAS LOCATED IN A SIDE BRANCH OF THE AXILLARY ARTERY. THE DISLODGED STENT WAS NOT AFFECTING FLOW TO THE AREA, AND WAS LEFT UNDEPLOYED IN A SIDE BRANCH OF THE AXILLARY ARTERY. TO COMPLETE THE TREATMENT OF THE RCA, THE LESION WAS PREDILATED AND ANOTHER 2.5X8MM STENT WAS IMPLANTED WITH GOOD ANGIOGRAPHIC RESULT. NO FURTHER PATIENT COMPLICATIONS OCCURRED. PATIENT'S STATUS IS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H749389388270 0013066299

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention CHOICE PT GUIDE WIRE