BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ (TM)

    MDR report key: 2180560 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-03120
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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

    THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE HYPOTUBE. THE BREAK WAS LOCATED AT 22CM DISTAL TO THE STRAIN RELIEF. A DETAILED EXAMINATION OF THE BREAK SITE IDENTIFIED THAT THE BREAK OCCURRED AS A RESULT OF A SEVERE KINK THAT DEVELOPED IN THE HYPOTUBE. ONE OTHER KINK WAS NOTED IN THE HYPOTUBE SHAFT AT 61CM PROXIMAL TO THE TIP. BOTH THE BREAK AND THE KINK IN THE SHAFT IS CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE SHAFT. NO ISSUES EXISTED WITH THE PROFILES OF THE CRIMPED STENT, BALLOON AND TIP. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A SHAFT FRACTURE OCCURRED. THE SHAFT OF THE 3.50 X 20MM LIBERTE BARE STENT DELIVERY SYSTEM FRACTURED. THE PHYSICIAN COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS REPORTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A SHAFT FRACTURE OCCURRED. THE SHAFT OF THE 3.50 X 20MM LIBERTE BARE STENT DELIVERY SYSTEM FRACTURED. THE PHYSICIAN COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTÉ (TM) STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893820350 13383887

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR