MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER

Model Number	352506100E
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reported while attempting to place an oe filter via brachial access utilizing an otw technique.After deliver sheath was positioned, when using the dilator to push the filter, resistance was met when the filter reached the brachial/svc junction.The filter would not advance and the dilator was removed.Next, the delivery sheath was pulled out with wire (stiff glide) still in in place.After inspecting the sheath and not seeing the filter it was realized that the filter had deployed when pulling out the delivery sheath.The filter had deployed at the axillary junction.The filter was snared and removed.A second attempt with new oe was attempted.
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.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, filter, delivery catheter sheath, and dilator.A borescope was used to examine the inside of the filter and upon examination it was found that their tears on the inner lining.The complaint is confirmed.The most likely cause of this defect is delamination of the inner liner within the delivery catheter sheath.This issue could impede the advancement of the filter through the sheath which caused the resistance.A sustaining engineering project has been initiated to identify the root cause of the delamination issue and to develop and implement an appropriate corrective action.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Common Device Name: OPTION ELITE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19274499
• Report Number: 0001625425-2024-01018
• Device Sequence Number: 15036745
• Product Code: DTK
• UDI-Device Identifier: 00886333222346
• UDI-Public: 00886333222346
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 08/02/2026
• Device Model Number: 352506100E
• Device Lot Number: 11491069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 03/29/2025
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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