MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE 100CM RETRIEVABLE VENA CAVA FILTER SYSTEM; RETRIEVABLE IVC FILTER

Model Number	352506100E
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is indicated as unavailable for evaluation.Without the device or any images in-vivo to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.
Event or Problem Description
According to the notice received by way of a civil action complaint, the patient was prescribed and implanted with an option elite vena cava filter on or about (b)(6) 2019 by dr.(b)(6).The complaint alleges there was embedment and tilt post-implant.The filter was unable to be removed from the inferior vena cava.Argon¿s attorneys are attempting to gather additional information.

• Brand Name: OPTION ELITE 100CM RETRIEVABLE VENA CAVA FILTER SYSTEM
• Common Device Name: RETRIEVABLE IVC FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10611434
• Report Number: 1625425-2020-00542
• Device Sequence Number: 2628416
• Product Code: DTK
• UDI-Device Identifier: 00886333222346
• UDI-Public: 00886333222346
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K143405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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: 07/21/2021
• Device Model Number: 352506100E
• Device Catalogue Number: 352506100E
• Device Lot Number: Q1384177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2020
• 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