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

Model Number	352506100E
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is unavailable for evaluation.Without such evidence to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
While removing the dilator from the option elite ivc filter deployment sheath, the distal marker of the dilator came off against the sheath tip and embolized to the patient's right lung.The dilator removal was done over an amplatz wire and in a smooth fashion without resistance or manipulation.This embolized object represents an approximately 2.5 mm circular, thin metallic marker that would be near impossible to retrieve endovascularly in the physician's opinion.Additionally, the patient was tachycardic, hypoxic, and had significant pulmonary injury related to covid.Any attempt at endovascular retrieval would have resulted in more harm to the patient than retaining the metallic marker.Patient is also not a candidate for open surgical retrieval of the marker.This tiny marker is inconsequential to the patient's pulmonary function per physician's opinion.Our representative was notified of the event and came to the facility to take photos of the sheath.The device was not released to the representative and at this time status regarding releasing it is pending.The representative came to the facility and took photos of the device.The device was not released to the representative.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Common Device Name: RETRIEVABLE IVC FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12522939
• Report Number: 0001625425-2021-01084
• Device Sequence Number: 1113890
• Product Code: DTK
• UDI-Device Identifier: 00886333222346
• UDI-Public: 00886333222346
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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
• Device Expiration Date: 01/15/2024
• Device Model Number: 352506100E
• Device Catalogue Number: 352506100E
• Device Lot Number: 11347150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other