MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 08/24/2022

Event Type  Injury  

Manufacturer Narrative

Sample has not been returned.It is unknown if sample will get returned or not.A follow-up report will be submitted when new information becomes available.

Event Description

Option elite ivc filter found to be multiply fractured.Removed filter and fractured fragment retained locally with forceps.Fda safety report id.

Event Description

Option elite ivc filter found to be multiply fractured.Removed filter and fractured fragment.Retained locally with forceps.Fda safety report id.

Manufacturer Narrative

According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.

• Brand Name: OPTION ELITE
• Type of Device: 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: 15485844
• MDR Text Key: 300581979
• Report Number: 0001625425-2022-01103
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other