BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CP STENT

    MDR report key: 8161187 · Received December 13, 2018

    Report

    Report Number
    1318694-2018-00017
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 15, 2018
    Report Date
    December 13, 2018
    Manufacturer
    NUMED, INC.
    Product Code
    PNF
    PMA / PMN Number
    P150028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RETURNED TO NUMED FOR EVALUATION. IF THE DEVICE IS RETURNED AND ANYTHING IS FOUND THAT WILL AFFECT OR CHANGE THIS REPORT, A FOLLOW-UP MDR REPORT WILL BE SENT. THE DEVICE WAS BEING USED OFF-LABEL. THIS DEVICE IS ONLY APPROVED FOR USE IN COARCTATION OF THE AORTA. THEY PHYSICIAN WAS USING THIS DEVICE FOR LPA STENTING, WHICH IS AN OFF-LABEL USE. STENT MIGRATION IS A KNOWN POTENTITAL COMPLICATION FOR STENTS AND IS LISTED IN THE INSTRUCTIONS FOR USE. UPDATE: THE DEVICE WAS RETURNED ON 01/10/2018. THE STENT IS TOO DEFORMED FOR ANALYSIS. ADDITIONAL INFORMATION FROM THE PHYSICIAN WAS ALSO RETURNED. THE PHYSICIAN STATED THAT HE MOUNTED THIS STENT ON A Z-MED CATHETER. IT IS LIKELY THAT THE STENT WAS NOT FULLY EXPANDED TO THE DESIRED DIAMETER OF 14MM. A LETTER FROM THE PHYSICIAN STATES THAT THE BALLOON WAS INFLATED TO 4 ATM. 14MM Z-MEDS HAVE A RATED BURST PRESSURE OF 6 ATM. THERE IS A WARNING IN THE Z-MED IFU THAT STATES : THIS CATHETER IS NOT INTENDED FOR USE WITH STENTS."

    Description of Event or Problem · 0

    AS PER THE REPORT FROM THE FOREIGN MANUFACTURER AND PHYSICIAN - "AFTER DEPLOYMENT, LPA STENT EMBOLIZED TO MPA UPON REMOVAL OF WIRE. ATTEMPTS TO REDEPLOY IT IN LPA OR RPA FAILED. THE STENT WAS THEN SNARED OUT."

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO NUMED FOR EVALUATION. IF THE DEVICE IS RETURNED AND ANYTHING IS FOUND THAT WILL AFFECT OR CHANGE THIS REPORT, A FOLLOW-UP MDR REPORT WILL BE SENT. THE DEVICE WAS BEING USED OFF-LABEL. THIS DEVICE IS ONLY APPROVED FOR USE IN COARCTATION OF THE AORTA. THEY PHYSICIAN WAS USING THIS DEVICE FOR LPA STENTING, WHICH IS AN OFF-LABEL USE. STENT MIGRATION IS A KNOWN POTENTIAL COMPLICATION FOR STENTS AND IS LISTED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    AS PER THE REPORT FROM THE FOREIGN MANUFACTURER AND PHYSICIAN - "AFTER DEPLOYMENT, LPA STENT EMBOLIZED TO MPA UPON REMOVAL OF WIRE. ATTEMPTS TO REDEPLOY IT IN LPA OR RPA FAILED. THE STENT WAS THEN SNARED OUT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001981 CP STENT AORTIC STENT PNF NUMED, INC. 425 CP-0757

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention