BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERED CP STENT

    MDR report key: 6177001 · Received December 15, 2016

    Report

    Report Number
    1318694-2016-00012
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 23, 2016
    Report Date
    December 15, 2016
    Manufacturer
    NUMED, INC.
    Product Code
    PNF
    UDI-DI
    04046964898921
    PMA / PMN Number
    P150028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DETACHMENT OF THE COVERING HAS BEEN CONFIRMED. THE COVERING IS NOT DAMAGED AND FOUR GLUE SPOTS ARE VISIBLE ON THE COVERING WHERE THEY WERE ATTACHED. THE STENT HAS BEEN SLIGHTLY FLATTENED AND IS BENT AT THE SECOND ROW OF WELDS. THE ZIGS ARE OVERLAPPED, WHICH IS A SIGN OF OVER CRIMPING. IT IS POSSIBLE THAT THE HEMOSTASIS VALVE TOOL DID NOT FULLY DEFEAT THE VALVE, CAUSING THE COVERING TO DETACH. THE MOUNTING PROCEDURE INCLUDED WITH THE INSTRUCTIONS FOR USE STATES: "INSERT THE LEADING EDGE OF THE TOOL INTO THE HEMOSTASIS VALVE OF THE SHEATH. THE TOOL MUST COLLAPSE THE ENTIRE HEMOSTASIS VALVE TO THE SIDES OF THE INTRODUCER TO ALLOW THE COVERED STENT TO PASS." THE STENT WAS BEING USED OFF-LABEL. IT IS ONLY APPROVED FOR COARCTATION OF THE AORTA.

    Description of Event or Problem · 1

    PER THE REPORT FROM THE DISTRIBUTOR: "COVER FELL OFF WHEN REMOVING THE PROTECTOR SHEATH. USED 12F PROTECTOR SHEATH, 12F COOK SHEATH, 14 X 4.5 BIB. MOUNTED DRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828558 COVERED CP STENT AORTIC STENT PNF NUMED, INC. 427 CCP-0515 04046964898921

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR