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

Model Number 352506070E

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The filter legs of the first option elite ivc filter that was used did not open in the ivc.The legs looked constricted.That filter had to be retrieved and a new option elite was opened and placed.

Manufacturer Narrative

Affected product is anticipated to be returned.A follow up will be submitted once the product is returned and investigation has been completed.

Event Description

The filter legs of the first option elite ivc filter that was used did not open in the ivc.The legs looked constricted.That filter had to be retrieved and a new option elite was opened and placed.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.Quality engineer and complaint analyst reviewed the sample returned from the customer.Customer returned only loose filter (unloaded filter from cartridge).Filter was put in warm water approximately for 5 seconds and filter opened normally without any issue and there were no damage found in the filter.Therefore, this complaint was not confirmed.Since the product complaint mode could not be duplicate during the evaluation, the complaint was not confirmed, and no further evaluation will be conducted at this time.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• 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: 12869755
• MDR Text Key: 283784762
• Report Number: 0001625425-2021-01132
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11386930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other