BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTION ELITE RETRIEVABLE VENA CAVA FILTER

    MDR report key: 19640143 · Received June 29, 2024

    Report

    Report Number
    0001625425-2024-01053
    Event Type
    Malfunction
    Date Received
    June 29, 2024
    Date of Event
    May 28, 2024
    Report Date
    March 19, 2025
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    DTK
    UDI-DI
    00886333217151
    PMA / PMN Number
    K133243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT WAS CONDUCTED. NO DEVIATIONS OR NON-CONFORMANCES WERE FOUND. NO SAMPLE WAS RETURNED HOWEVER MULTIPLE IMAGES WERE PROVIDED. UPON INSPECTION OF THE PROVIDED IMAGES, IT WAS FOUND THAT THE INNER LINER OF THE DELIVERY CATHETER SHEATH WAS DELAMINATED AND THE FILTER WAS NOT ABLE TO EXPAND. THE COMPLAINT IS CONFIRMED. THE MOST PROBABLE CAUSE FOR THE FILTER NOT BEING ABLE TO OPEN IS DELAMINATION OF THE INNER LINING OF THE SHEATH. THIS COULD RESULT IN THE LINING WRAPPING AROUND THE FILTER, RESTRICTING EXPANSION AND NOT ALLOWING THE FILTER TO FULLY OPEN. SUSTAINING ENGINEERING STUDY SE-2024-009 HAS BEEN INITIATED TO INVESTIGATE THE ROOT CAUSE OF THE DELAMINATION ISSUE AND TO IMPLEMENT A CORRECTIVE ACTION.

    Description of Event or Problem · 0

    OPTION ELITE FILTER PLACEMENT WAS PERFORM VIA JUGULAR APPROACH WITH CURVE PUSHER TECHNIQUE. THE CURVE PUSHER WAS USED TO DEPLOY THE FILTER THROUGH THE SHEATH BUT RESISTANCE OCCUNED HOWEVER THE FILTER WAS UNABLE TO EXPAND THE LEG. THE INNER OF THE SHEATH WAS DETACHED FTOM THE SHEATH AND WRAP THE FILTER RESULTING IN THE FILTER WAS UNABLE TO EXPAND THE LEG AND THE ATRIEVE COULD NOT SNARE THE HOOK OF FILTER. THE DOCTOR USED ANOTHER OPTION OF RETRIEVAL BY USING ALN RETRIEVAL KIT AND SUCCESS FINALLY THE DOCTOR PERFORMED ALN FILTER PLACEMENT INSTEAD OF OPTION ELITE. THE PRODUCT WITH THE PROBLEM WAS NOT RETURNED BECAUSE THE PATIENT HAS HIV

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183771 OPTION ELITE RETRIEVABLE VENA CAVA FILTER OPTION ELITE DTK ARGON MEDICAL DEVICES 352506070E 11503284 00886333217151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown