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

Catalog Number 352506070E

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Thrombus (2101)

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

No product was returned, and no lot number was provided for review.As such, a definitive root cause could not be determined for this case.Many factors can influence the success of a filter retrieval, including technique chosen, how long the device was indwelling, and patient physiologic factors.Additionally, based on the information provided, it is unclear whether the complaint represents a filter malfunction or a malfunction of the retrieval kit.Also, according to the instructions for use, removing an option filter with thrombus is contraindicated and can be hazardous to the patient.

Event Description

Inferior vena cava (ivc) filter placed.Upon attempt to retrieve using kit was unsuccessful.The device did not come with sheath through internal jugular (ij)vein.The patient had surgery to remove and thrombus found at that time.Not known if problem was with ivc filter or the retrieval kit.

• 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: 6238890
• MDR Text Key: 64729898
• Report Number: 1625425-2016-00103
• 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: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR