BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERED CP STENT

    MDR report key: 10587612 · Received September 25, 2020

    Report

    Report Number
    1318694-2020-00010
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    August 8, 2020
    Report Date
    September 25, 2020
    Manufacturer
    NUMED, INC.
    Product Code
    PNF
    PMA / PMN Number
    P150028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED, AND NO ISSUES WERE NOTED. THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. THE STENT WAS RETURNED FOR REVIEW. THE COVERING WAS COMPLETELY DETACHED. 4 ADHESIVE SPOTS ARE VISIBLE ON THE COVERING. THE STENT HAS BEEN CRIMPED DOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN / DISTRIBUTOR. THE COVERED CP STENT HAD BEEN MOUNTED ON A CATHETER THAT IS NOT INTENDED FOR STENT PLACEMENT. THE CATHETER USED IS (2) FRENCH SIZES SMALLER THAN THE RECOMMENDED BIB CATHETER RESULTING IN THE STENT BEING CRIMPED TO A SMALLER DIMENSION THAN WHAT IS INTENDED. WHEN THE STENT IS CRIMPED ON A SMALLER CATHETER, IT CAUSES THE ZIGS TO OVERLAP, WHICH CAUSES IT TO INTERFERE WITH / BREAK THE ADHESIVE THAT IS USED TO ATTACH THE COVERING TO THE STENT FRAME. AS STATED IN THE INSTRUCTIONS FOR USE, THE BIB CATHETER IS THE DEVICE USED FOR ALL TESTING THAT WAS PERFORMED ON THE COVERED CP STENT. ALL COVERED STENT ARE INSPECTED AT FINAL QC WO ENSURE THAT EACH COVERING HAS 4 ACCEPTABLE GLUE SPOTS. A SAMPLES FROM EACH LOT IS TESTED FOR COVERING ADHESION STRENGTH. THE SAMPLE FROM THIS LOT OF STENTS HAD A COVERING ADHESION STRENGTH OF 2.84 LBS, WHICH IS WELL ABOVE THE 1.5 LB MINIMUM.

    Description of Event or Problem · 1

    AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR, THIS TO REPORT AN INCIDENT DURING DEPLOYMENT OF NUMED COVERED CP STENT SIZE CP8Z34 ON (B)(6) 2020. DURING CRIMPING OF STENT ON BALLOON, IT WAS NOTED THE COVERING ON THE STENT IS NEAR COMPLETELY DETACHED FROM THE METALLIC STENT, WHICH PREDISPOSED THE COVERING TO BE COMPLETELY SEPARATED INSIDE THE SHEATH OR UPON DEPLOYMENT IN PATIENT, SO STENT WAS NOT USED, AND RETURNED TO DISTRIBUTOR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052623 COVERED CP STENT AORTIC STENT PNF NUMED, INC. 427 CCP-0862

    Patients

    Seq Age Sex Outcome Treatment
    1