MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION RETRIEVABLE VANA CAVA FILTER SYSTEM; OPTION ELITE

Model Number	352506070
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned, and device evaluation has begun but not yet completed.A follow-up report will be submitted once the device evaluation has been completed.
Event or Problem Description
Upon removal noticed a leg of the filter was missing and was not able to be retrieved.
Event or Problem Description
Upon removal noticed a leg of the filter was missing and was not able to be retrieved.
Additional Manufacturer Narrative
Device evaluation is still ongoing and not yet completed.A follow-up report will be submitted once the device evaluation has been completed.
Additional Manufacturer Narrative
A review of the returned product from the customer was performed.Visual inspection of the returned sample from the customer found, filter leg was broken during the retrieval procedure and unable to be retrieved.Upon removal it was noticed a leg of the filter was missing and was not able to be retrieved.Physical review of the sample found one strut(leg) was broken and the complaint was confirmed.Based on the fractured surface study, the origin of fracture could not be concluded because there is no inclusion or void at initiation site.Therefore, there is nothing in the manufacturing.Process that could have caused the fracture to occur during retrieval of the filter.
Event or Problem Description
Upon removal noticed a leg of the filter was missing and was not able to be retrieved.

• Brand Name: OPTION RETRIEVABLE VANA CAVA FILTER SYSTEM
• Common Device Name: OPTION ELITE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 12657533
• Report Number: 0001625425-2021-01100
• Device Sequence Number: 4852611
• Product Code: DTK
• UDI-Device Identifier: 00886333217519
• UDI-Public: 00886333217519
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2021

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 Model Number: 352506070
• Device Catalogue Number: 352506070E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• 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: 09/27/2021
• Supplement Date Received by Manufacturer: 09/27/2021; 09/27/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/04/2021; 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown