BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERED CP STENT

    MDR report key: 6177128 · Received December 15, 2016

    Report

    Report Number
    1318694-2016-00014
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    August 17, 2016
    Report Date
    December 15, 2016
    Manufacturer
    NUMED, INC.
    Product Code
    PNF
    UDI-DI
    04046964898792
    PMA / PMN Number
    P150028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DETACHED COVERING HAS BEEN CONFIRMED. THE COVERING IS UNDAMAGED AND FOUR GLUE SPOTS ARE VISIBLE ON THE COVERING. THE OD OF THE STENT IS 0.167". THE STENTS HAVE AN OD OF 0.181 WHEN SHIPPED FROM NUMED. IT APPEARS THE COVERING BECAME DETACHED WHEN THE PHYSICIAN ATTEMPTED TO REMOVE IT FROM THE SHEATH TO RE-CRIMP THE STENT. A SPECIAL TOOL NEEDS TO BE USED TO INSERT THE STENT THROUGH THE HEMOSTASIS VALVE, SO THAT THE COVER WILL NOT CATCH. WHEN PULLING BACK THROUGH THE HEMOSTASIS VALVE, THE COVERING WILL CATCH AND DETACH FROM THE STENT. THE OD OF THE STENT WAS 0.167" WHICH IS VERY CLOSE TO THE OD OF THE STENT WHEN SHIPPED FROM NUMED. IT IS LIKELY THAT THE STENT SHIFTED BECAUSE IT WAS NOT FULLY CRIMPED ON THE BALLOON. THIS INDIRECTLY LED TO THE COVERING ISSUE SINCE IT HAD TO BE REMOVED BACK THROUGH THE HEMOSTASIS VALVE IN ORDER TO RE-CRIMP THE STENT ON THE BALLOON. THE INSTRUCTIONS FOR USE STATES THAT THE STENT SHOULD BE CRIMPED UNTIL NO MOVEMENT IS FELT ON THE CATHETER. IT ALSO STATES TO PLACE A SMALL AMOUNT OF UNDILUTED CONTRAST TO COAT THE STENT AND IMPROVE ADHERENCE TO THE BALLOON. NUMED IS UNABLE TO CONFIRM WHETHER OR NOT THIS WAS FOLLOWED. THE DISTRIBUTOR HAS STATED THAT NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    AS PER THE REPORT FROM THE DISTRIBUTOR: "DURING DELIVERY, STENT WAS FOUND TO HAVE SHIFTED ON THE BIB. THEN THE PHYSICIAN TRIED TO RE-CRIMP THE STENT, THE COVER FELL OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825932 COVERED CP STENT AORTIC STENT PNF NUMED, INC. 427 CCP-0592 04046964898792

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR