BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT? RP ENDOPROSTHESIS

    MDR report key: 3882153 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03470
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    March 10, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P940019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION FOUND THAT THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH THE OUTER SHEATH FLUSH TO THE TIP. IT WAS ALSO NOTED THAT THE SHAFT OF THE DEVICE WAS KINKED AT VARIOUS POSITIONS ALONG ITS LENGTH. THE INVESTIGATOR WAS ABLE TO PARTIALLY DEPLOY THE STENT AND IT WAS OBSERVED THAT TWO OF THE DISTAL STENT WIRES WERE UNCROSSED. ONCE THE OUTER SHEATH WAS RETRACTED IT WAS NOTED THAT THE INNER SHAFT WAS KINKED IMMEDIATELY PROXIMAL TO THE DISTAL MARKERAND. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT DEPLOYMENT ISSUE OCCURRED. THE 10X39X135/ ILIAC WALLSTENT RP ENDOPROSTHESIS STENT WAS SELECTED BUT IT WAS FOUND OUT THAT THE STENT WAS PARTIALLY DEPLOYED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358594 WALLSTENT? RP ENDOPROSTHESIS STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY M001712350

    Patients

    Seq Age Sex Outcome Treatment
    1