BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERED CP STENT

    MDR report key: 17336820 · Received July 17, 2023

    Report

    Report Number
    1318694-2023-00006
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 21, 2023
    Report Date
    July 17, 2023
    Manufacturer
    NUMED, INC.
    Product Code
    PNF
    PMA / PMN Number
    P150028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE STENT WAS RETURNED IN A BAG ALONG WITH ITS OUTER POUCH. THE COVERING AND STENT ARE CLEAN. ALL FOUR ADHSEIVE SPOTS ARE DETACHED. ALL GLUE SPOTS ARE VISIBLE. THE ENDS OF THE STENT HAVE BEEN CRIMPED DOWN. THE ODS AT THE END OF THE STENT MEASURED 0.138" AND 0.131" . THE ZIGS AT EACH END OF THE STENT ARE OVERLAPPED. ALL COVERED STENTS ARE INSPECTED FOR PROPER COVERING ATTACHMENT IN FINAL INSPECTION. A SAMPLE FROM EACH LOT IS TESTED FOR COVERING STRENGTH. THE SAMPLE FROM THIS LOT FAILED AT 2.60 LBS, WHICH IS WELL ABOVE THE 1.5 LB MINIMUM REQUIRED. THE PRODUCTION TRAVELER (DHR) WAS REVIEWED AND NO ISSUES WERE FOUND. ALL DEVICES IN THIS LOT MET THE CRITERIA FOR RELEASE AND DISTRIBUTION. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES.

    Description of Event or Problem · 0

    AS PER A REPORT FROM THE USER FACILITY AND FOREIGN DISTRIBUTOR - A 4.5CM COVERED CP STENT WS MOUNTED ON A 20MM/4.5CM BIB CATHETER, AND THE STENT-BALLOON COMPLE WAS INTRODUCED INTO THE 14FR D'VILL LONG SHEATH WITH THE STANDARD INTRODUCER THAT COMES WITH THE COVERED CP STENT. DURING ADVANCEMENT OF THE STENT-BALLOON COMPLEX IN THE LONG SHEATH, THE STENT WAS FOUND TO HAVE SLIPPED PROXIMALLY ON THE BALLOON CATHETER AND HENCE THE WHOLE SYSTEM INCLUDING THE BIB CATHETER, THE LONG SHEATH AND TOGETHER WITH THE COVERED STENT WERE RETRIEVED WITH THE GUIDEWIRE POSITION MAINTAINED. THE COVERED STENT WAS NOTED TO HAVE LODGED IN THE MIDDLE OF THE LONG SHEATH BY FLUOROSCOPY. HOWEVER, THE PTFE MEMBRANE OF THE COVERED CP STENT AND THE CP STENT WERE FOUND TO BE SEPARATED WHEN THE STENT WAS FLUSHED OUT OF THE LONG SHEATH (WITH GENTLE SALINE INJECTION VIA THE SIDE-ARM OF THE LONG SHEATH). THE PTFE MEMBRANE OF THE COVERED STENT WAS FOUND DETACHED COMPLETELY FROM THE CP STENT. BOTH THE STENT AND THE PTFE MEMBRANE WERE INTACT. THERE WAS NO MATERIAL FOUND LEFT IN THE PATIENT. THE INTENDED PROCEDURE OF COVERED STENT IMPLANTATION WAS COMPLETED USING A NEW 4.5CM COVERED CP STENT MOUNTED ON THE SAME 20MM/4.5CM BIB CATHETER AND DELIVERED VIA THE SAME D'VILL LONG SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615592 COVERED CP STENT AORTIC STENT PNF NUMED, INC. 427.1 CCP-1131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown