BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERED CP STENT

    MDR report key: 10828360 · Received November 12, 2020

    Report

    Report Number
    1318694-2020-00012
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 12, 2020
    Manufacturer
    NUMED, INC.
    Product Code
    PNF
    UDI-DI
    04046964898921
    PMA / PMN Number
    P150028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO ISSUES WERE NOTED. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. A REVIEW OF THE COMPONENT LOT NUMBERS USED TO MANUFACTURE THIS LOT OF STENTS WAS ALSO REVIEWED AND NO OTHER COMPLAINTS WERE FOUND. ALL COVERED STENTS ARE TESTED AT FINAL QC TO ENSURE THAT EACH COVERING HAS (4) ACCEPTABLE GLUE SPOTS. A SAMPLE FROM EACH LOT IS TESTED FOR COVERING ADHESION STRENGTH. THE SAMPLE FROM THIS LOT HAD A COVERING ADHESION STRENGTH OF 3.2 LBS, WHICH IS WELL ABOVE THE 1.5 LB MINIMUM. THE COMPLAINT STENT WAS RETURNED AND EVALUATED. THERE IS CONTRAST ON THE STENT. TWO ADHESIVE SPOTS ARE DETACHED, OTHERWISE THE COVERING IS INTACT. THE STENT IS FLATTENED ON ONE END AND IS BENT. AS PER THE INSTRUCTIONS FOR USE, THE PHYSICIAN SHOULD "ALWAYS PLACE AN APPROPRIATE SIZED GUIDEWIRE OR MANDREL THROUGH THE BALLOON CATHETER GUIDEWIRE LUMEN WHILE PREPPING THE BALLOON AND CRIMPING THE STENT." THE REPORT FROM THE USER FACILITY STATED THAT THE MANDREL WAS NOT USED. THE IFU STATES: "ALWAYS PLACE AN APPROPRIATE SIZED GUIDEWIRE OR MANDREL THROUGH THE BALLOON CATHETER GUIDEWIRE LUMEN WHILE PREPPING THE BALLOON AND CRIMPING THE STENT." "THE ROLLING ACTION SHOULD BE DONE IN THE SAME DIRECTION AS THE FOLDS IN THE COVERING. AVOID UNWRAPPING THE FOLDS IN THE COVERING. THIS COULD CAUSE IT TO CATCH AND TEAR OFF OF THE STENT."

    Description of Event or Problem · 1

    AS REPORTED TO NUMED BY THE DISTRIBUTOR / USER FACILITY - WHILE CRIMPING THE STENT ONTO A 24X4 BIB THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE COVERING WAS SLIDING OFF THE STENT. THE INDICATION THE PHYSICIAN AS USING THE PRODUCT FOR: INTIMAL TEAR IN RV-PA CONDUIT. THERE WAS NO DIFFICULTY MOUNTING THE STENT. CRIMPING WAS MANUAL, BY HAND. THE RING MANDRIL WAS NOT USED DURING THE CRIMPING PROCESS. THE STENT WAS NOT USED ON THE PATIENT. THE BLUE INTRODUCER TOOL PROVIDED BY NUMED WAS NOT USED. THEY DID NOT ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE AT ANY TIME. CONTRAST MEDIA WAS USED DURING PREP. THE BALLOON WAS NOT INFLATED, NO INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292607 COVERED CP STENT AORTIC STENT PNF NUMED, INC. 427 CCP-1208 04046964898921

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR