BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ¿

    MDR report key: 2831549 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-06966
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: AN EXAMINATION OF THE CRIMPED STENT FOUND THAT THE STENT WAS PULLED DISTALLY ON THE BALLOON. AS A RESULT THE PROXIMAL EDGE OF THE CRIMPED STENT WAS POSITIONED AT 1MM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. NO DAMAGE NOTED WITH THE STENT STRUTS. THE BALLOON DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE THE STENT MOVED ON THE DELIVERY CATHETER. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 75% STENOSED, 4.0X12-15MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 4.016MM LIBERTE BARE METAL STENT HAD BEEN SELECTED TO TREAT THE TARGET LESION. WHEN THE DEVICE WAS UNPACKED, IT WAS NOTICED THA THE STENT WAS ABLE TO BE MOVED ALONG THE SHAFT OF THE DELIVERY CATHETER. THE PROCEDURE WAS COMPLETED WITH THE IMPLANT OF A 4.01X15MM NON-BSC STENT. 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 THE STENT MOVED ON THE DELIVERY CATHETER. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 75% STENOSED, 4.0X12-15MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 4.016MM LIBERTE BARE METAL STENT HAD BEEN SELECTED TO TREAT THE TARGET LESION. WHEN THE DEVICE WAS UNPACKED, IT WAS NOTICED THA THE STENT WAS ABLE TO BE MOVED ALONG THE SHAFT OF THE DELIVERY CATHETER. THE PROCEDURE WAS COMPLETED WITH THE IMPLANT OF A 4.01X15MM NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893816400 0013972064

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR