MAUDE Adverse Event Report: ARGON MEDICAL DEVICES IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Situation an inferior venacava (ivc) filter had a retention barb at the tip of one of the filter legs shear off during explant from a patient.Barb remained in patient as a retained foreign body post procedure.Background patient had an ivc filer placed by (b)(6) back in (b)(6) 2024 for lle deep vein thrombosis (dvt) & bilateral pulmonary embolism (bilat pe).Patient returned to (b)(6) for removal but, due to the positioning of the filter against the inferior venacava, (b)(6) unable to remove.Patient seen by our medical doctor (md) and scheduled for ivc removal at ech.During the explant of the ivc filter, one of the retention barbs located at the distal end of the ivc legs sheared off.Under fluoroscopy, the md was able to determine that the foreign body had migrated to the pulmonary artery.Assessment no harm to the patient noted.Ivc filter was sequestered by vendor rep.Manufacturer was notified and they will be communicating with quality/risk about the incident.Recommendation from a procedural perspective, this is an unplanned event with a retained foreign body due to a potential defect in the implant.We did note post procedure deviations by both the provider and staff that we needed to address.
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 were unable to review the manufacturing and inspection records for this lot as the lot # and product # was missing.Additionally, no photographic or visual evidence of any kind was provided, which would have allowed the allegation to be reviewed.Barb detaching from one of the filter legs may have resulted from a variety of potential factors such as excessive tissue ingrowth or forceful retrieval.However, without receiving the sample, we are unable to conduct a comprehensive investigation.As a result, we cannot determine a definitive root cause or establish an appropriate corrective action at this time.Additional information provided in h.6 and h.11.

• Brand Name: IVC 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 75758 ; 9036759321
• MDR Report Key: 23551121
• Report Number: 0001625425-2025-01129
• Device Sequence Number: 21276052
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (Y/N): N
• 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: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White