MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE 100CM; FILTER, INTRAVASCULAR CARDIOVASCULAR

Model Number	352506100E
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Option elite ivc filter placement via brachial approach, 100cm kit.The patient had scoliosis, and pronounced curvature to the ivc was present.The otw technique was attempted; the wire would not load through the filter cartridge.Attempted to load the wire through the other end of the cartridge to see if it would load and potentially open up the passageway.It did pass.Thinking this opened it up, the wire was passed through the cartridge in the appropriate direction, but it would not go smoothly.The wire from the patient was removed, and the otw technique was abandoned.The cartridge was loaded, snapped onto the delivery sheath, and the pusher was used.No resistance was felt, and the filter was deployed.Upon deployment, the legs would not open.Attempts were made to open the legs.At one, each individual leg was seen (not tangled) but wouldn't fully expand.The filter was retrieved with argon rk via jugular, and a new oe (70cm filter via 100cm kit through rk kit) was placed via jugular approach.Prior to 2nd placement, the curvature of the ivc was marked on the screen to avoid placement in the curvature.The filter was placed successfully.
Additional Manufacturer Narrative
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
We conducted a thorough review of the manufacturing and inspection records for this lot and found no deviations or non-conformances.Unfortunately, we did not receive any samples for evaluation, nor did we receive any photographic or visual evidence that would have allowed us to review the allegation in detail.Without this necessary evidence, we are unable to perform a thorough investigation or determine a root cause and corrective action at this time.As a result, no corrective action is required at this point.However, if samples are returned at a later date, we would be happy to reopen this complaint for re-evaluation.Additional information provided in h.6.And h.11.

• Brand Name: OPTION ELITE 100CM
• Common Device Name: FILTER, INTRAVASCULAR CARDIOVASCULAR
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 22301913
• Report Number: 0001625425-2025-01042
• Device Sequence Number: 8562472
• Product Code: DTK
• UDI-Device Identifier: 00886333222346
• UDI-Public: (01)00886333222346(17)060727(10)11488335
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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 Expiration Date: 07/27/2026
• Device Model Number: 352506100E
• Device Lot Number: 11488335
• Was Device Available for Evaluation?: Yes
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2023
• 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