BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3192929 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04597
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE LIBERTÉ/VERIFLEX STENT DELIVERY SYSTEM (SDS) WAS RECEIVED WITH THE STENT AND LIBERTÉ/VERIFLEX SHELF BOX AND INNER PACKAGING POUCH. THE BATCH ON THE RETURNED PACKAGING AND THE HUB MATCHED THE REPORTED LOT NUMBER. THERE WAS BLOOD IN THE WIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THE STENT WAS SECURE ON THE BALLOON BETWEEN THE MARKERBANDS. THE MIDDLE OF THE STENT WAS BUNCHED UP AND WAS 10.5MM FROM THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. THE STENT WAS .5MM PAST THE DISTAL MARKERBAND. THERE WERE STENT IMPRESSIONS ON THE BALLOON INDICATING THE STENT WAS POSITIONED BETWEEN THE MARKERBANDS DURING MANUFACTURING. THERE WAS NO DAMAGE TO THE SDS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 80% STENOSED, 20MM IN LENGTH, DE NOVO, ECCENTRIC, TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS AND 3.5MM IN DIAMETER RIGHT CORONARY ARTERY. AT THE MOMENT TO PREPARE A 3.50MM X 20MM LIBERTÉ STENT DELIVERY SYSTEM (SDS) FOR ITS PLACEMENT, THE DEVICE WAS DETECTED THAT THE STENT WAS COMPRESSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.50MM X 20MM LIBERTE STENT DELIVERY SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 80% STENOSED, 20MM IN LENGTH, DE NOVO, ECCENTRIC, TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS AND 3.5MM IN DIAMETER RIGHT CORONARY ARTERY. AT THE MOMENT TO PREPARE A 3.50MM X 20MM LIBERTÉ STENT DELIVERY SYSTEM (SDS) FOR ITS PLACEMENT, THE DEVICE WAS DETECTED THAT THE STENT WAS COMPRESSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.50MM X 20MM LIBERTE STENT DELIVERY SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294351 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893820350 15426662

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR