MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER; FILTER, INTRAVASCULAR CARDIOVASCULAR

Model Number	352506070E
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A final report will be submitted upon investigation completion.
Event or Problem Description
Reporter stated after deploying an ivc filter (not over the wire) and the legs did not open.The filter was floating in the ivc.Tried to open the legs with a catheter/wire, but it didn¿t work and the filter tilted so it was decided to remove it and place a new one.When trying to retrieve the filter, the legs opened but the filter was suprarenal at that point.During the retrieval, the legs would not collapse.One of them even bent and folded on its own completely.Finally, the doctor was able to manipulate and retrieve.A new option filter was placed without issue.No patient injury or complications were reported.Device is available to send back.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Common Device Name: FILTER, INTRAVASCULAR CARDIOVASCULAR
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75758 ; 9036759321
• MDR Report Key: 23986284
• Report Number: 0001625425-2026-00920
• Device Sequence Number: 19991066
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: (01)00886333217151(17)281008(10)11641380
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K133243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 352506070E
• Device Lot Number: 11641380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown