MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. OPTION ELITE RETRIEVABLE VENA CAVA FILTER SYSTEM; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 352506070E

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2022

Event Type  malfunction  

Event Description

Two failures: same lot numbers, same case, but different issues.The filter comes loaded in a cartridge.There is a pin in the cartridge that needs to be removed prior to loading into the introducer.The pin was pulled to remove and the filter came out of the cartridge with the pin.New filter opened.No harm to patient.Second filter was opened from the same lot number.The filter was placed in the inferior vena cava (ivc) in the usual manner.The filter remained constrained.This filter is made from nitinol which should react to body temperature and expand to the fullest diameter.This filter failed to expand.New filter from a new lot number was opened and used to complete the procedure.No harm to patient.Manufacturer response for option elite ivc filter, (brand not provided) (per site reporter) product picked up for evaluation.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER SYSTEM
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 13885990
• MDR Text Key: 287824561
• Report Number: 13885990
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2022

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: 11393463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2022
• Date Report to Manufacturer: 03/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Sex: Female