BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1932118 · Received December 17, 2010

    Report

    Report Number
    2134265-2010-05675
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    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 MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE PROXIMAL END OF THE CRIMPED STENT WAS RAISED AND THE STENT STRUTS WERE BENT BACK DISTALLY. NO OTHER DAMAGE WAS VISIBLE ALONG THE ENTIRE LENGTH OF THE DEVICE. NO KINKS OR DAMAGE WAS NOTED ALONG THE ENTIRE LENGTH OF THE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE HARD, CALCIFIED LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 4.00X12MM LIBERTE BARE STENT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN TRIED MANY TIMES AND THEN FOUND THAT THE STENT STRUTS WERE DAMAGED. AT THIS POINT HE CHOSE TO END THE PROCEDURE AND SEND THE PATIENT TO SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LESION WAS 80% STENOSEED WHICH WAS LOCATED IN A MODERATLY TORTOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE DEVICE WAS REMOVED IN TACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE HARD, CALCIFIED LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 4.00X12MM LIBERTE BARE STENT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN TRIED MANY TIMES AND THEN FOUND THAT THE STENT STRUTS WERE DAMAGED. AT THIS POINT HE CHOSE TO END THE PROCEDURE AND SEND THE PATIENT TO SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE 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 H7493893812400 0012266769

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR