MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. OPTION IVC FILTER; RETRIEVABLE INFERIOR VENA CAVA FILTER

Catalog Number 352506070E

Device Problems Break (1069); Entrapment of Device (1212); Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

Sample device has not been returned to argon medical for evaluation, however it may be available.Argon will continue to request for the device return.Follow-up report will be provided by (b)(6) 2020.

Event Description

On (b)(6) 2019 dr.(b)(6) & dr.(b)(6) - patient came for filter removal and filter was tilted.Attempts were made to remove the filter using jugular approach; however, the superior hook of the filter was embedded.Multiple attempts were made to secure the hook.Dr.(b)(6) was invited to join dr.(b)(6) to help, and dr.(b)(6) accessed the right femoral and attempted to snare the filter.Eventually he was able to grasp the filter and attempted to pull the filter into the retrieval sheath.It was noted by both doctors that a leg of the filter had broken off.While visualizing that broken piece being removed, they noted an additional leg was broken and had traveled into the chamber of the heart.A team and amg were called to prepare for future complications.Dr.(b)(6) was eventually able to snare and remove the broken piece from the heart.Numerous issues have occurred with the argon device.Doctors will no longer use this device due to repeated device tilting and broken pieces.(b)(6) 2019 update: argons tilt.The argon filter scars and she said she can¿t get over the hook to remove it.She has had to put a pt.Under general anesthesia to remove the filters and it is a struggle to remove them.Number of occurrences: 10.Sample available: true.Lot number: multiple.

Manufacturer Narrative

The actual sample device was unavailable from the customer for evaluation.However, the customer supplied images for limited assessment of the device issue.Based on the images provided, the legs on the filter were broken, confirming the complaint.The clinical evaluation found that the filter demonstrated fracture from the retrieval attempt and torquing and flexion forces applied to it at points along the legs and interstices of the filter as opposed to fracture ¿ in situ¿ attributed to the general physiologic and functional state of the patient.It appears the filter was damaged by retrieval technique/devices and is not a filter ¿failure¿, thus a corrective action is not required at this time.If more information is provided in the future, the complaint will be re-evaluated as needed.

• Brand Name: OPTION IVC FILTER
• Type of Device: RETRIEVABLE INFERIOR VENA CAVA FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 9572394
• MDR Text Key: 189224377
• Report Number: 1625425-2020-00040
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): Y
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/02/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 352506070E
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention