BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTION ELITE RETRIEVABLE VENA CAVA FILTER

    MDR report key: 20030910 · Received August 22, 2024

    Report

    Report Number
    0001625425-2024-01085
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 22, 2024
    Report Date
    May 1, 2025
    Manufacturer
    ARGON MEDICAL DEVIES
    Product Code
    DTK
    UDI-DI
    00886333217151
    PMA / PMN Number
    K133243
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT WAS CONDUCTED, AND NO DEVIATIONS OR NON-CONFORMANCES WERE RECORDED. ONE SAMPLE WAS RETURNED BY THE CUSTOMER FOR REVIEW. THE CUSTOMER RETURNED THE PUSHER WIRE, CARTRIDGE, DELIVERY CATHETER SHEATH, AND DILATOR. HOWEVER, THERE WAS NO FILTER RETURNED FOR EVALUATION. WITHOUT THE RETURN OF PHYSICAL FILTER SAMPLES OR IMAGES OF THE REPORTED DEFECT, A THOROUGH INVESTIGATION INTO THE FILTER EXPANSION ISSUE CANNOT BE CONDUCTED, AND WE ARE UNABLE TO CONFIRM THE COMPLAINT. SINCE THE COMPLAINT CANNOT BE CONFIRMED, NO CORRECTIVE WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION PROVIDED IN D9, H3, H6 AND H11.

    Description of Event or Problem · 0

    REPORTER INDICATED "FILTER LEGS DID NOT FULLY OPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217973 OPTION ELITE RETRIEVABLE VENA CAVA FILTER OPTION ELITE DTK ARGON MEDICAL DEVIES 352506070E 11490779 00886333217151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown