BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTÉ?

    MDR report key: 3190562 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04469
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, STENT WAS DISLODGED INSIDE THE PATIENT. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A >=90 DEGREE BEND WAS NOTED IN THE LESION. UPON ADVANCING A 4.50MM X 24MM LIBERTÉ STENT, IT COULD NOT PASS THROUGH THE LESION BECAUSE THE STENT WAS FOUND OUT TO BE "MISSHAPED" AND THE STENT WAS DISLODGED INSIDE THE PATIENT. THE DISLODGED STENT WAS RETRIEVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290938 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893824450 15568452

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention