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); Difficult to Remove (1528); Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Sample device has not yet been returned to argon medical for investigation.It is currently unknown if the device or imaging evidence will be available for evaluation.Follow up with any additional details will be provided by 1/24/2020.

Event Description

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.Ross 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.

Manufacturer Narrative

As of the date of closure for this complaint, there have been no samples or visual evidence returned for evaluation.Without such evidence, determining root cause is not possible.

• 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: 9520424
• MDR Text Key: 173355592
• Report Number: 1625425-2019-00322
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352506070E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention