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

Catalog Number 352506070E

Device Problems Difficult to Remove (1528); Material Perforation (2205); Device Damaged by Another Device (2915)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

No product or case images have been received related to this complaint, therefore, the complaint could not be confirmed.As such, a definitive root cause could not be determined for this issue.The tilt of the filter was likely due to improper centering at the time of implantation/deployment.When the hook is tilted severely, as with this case where the hook was reported to have been against the vena cava wall, retrieval can be especially difficult.

Event Description

The doctor was removing an option filter and the hook was embedded in the anterior wall.Used a cook retrieval set and tried some advanced techiques to retrieve the filter.It ended up perforating the ivc and the patient had to have it surgically removed.Patient had to be hospitalized.The filter was implanted in (b)(6) 2016.

• Brand Name: OPTION ELITE IVC FILTER
• Type of Device: RETRIEVABLE INFERIOR VENA CAVA FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 6148709
• MDR Text Key: 61544459
• Report Number: 1625425-2016-00094
• Device Sequence Number: 1
• Product Code: DTK
• 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: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 352506070E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention