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

Model Number	352506100E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Report received via medsun reporting "surgeon deployed initial ivc [inferior vena cava] filter which malfunctioned, surgeon removed the device and confirmed via xray that no pieces of the device remaining within the pt, surgeon then deployed second ivc filter which remained implanted in pt.No harm to patient." additional information received from the customer indicating the sample is not available for return, images are not available, and the ivc filter insertion area was the left posterior upper leg.
Additional Manufacturer Narrative
After thoroughly reviewing the manufacturing and inspection records for this lot, we found no deviations or non-conformances.Based on the product experience report, it appears there was no sample available for return.Additionally, we did not receive any photographic or visual evidence that would have allowed us to further review your concern.Unfortunately, without the necessary evidence, we are unable to conduct a thorough investigation at this time.As a result, determining the root cause and corrective action is not feasible.If samples become available in the future, the complaint can be reopened for investigation.Additional information provided in h.6.And h.10.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• 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: 22373942
• Report Number: 0001625425-2025-01046
• Device Sequence Number: 4437172
• Product Code: DTK
• UDI-Device Identifier: 00886333222346
• UDI-Public: (01)00886333222346(17)260418(10)11471484
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 04/18/2026
• Device Model Number: 352506100E
• Device Lot Number: 11471484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Unknown