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

Model Number 352506070E

Device Problems Unraveled Material (1664); Material Protrusion/Extrusion (2979); Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

The sample is expected to return for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.

Event Description

When placing the filter, the legs did not expand.Had to go femoral to retrieve and place another.Once retrieved, they noticed a suture like string around legs of filter and material coming out of the sheath.

Manufacturer Narrative

An evaluation of two devices returned found the filters were encapsulated in ptfe lining from the sheath, confirming the complaint.Sheath delamination with this product is a known problem that is actively being investigated.Capa c-2020-052 has been initiated to capture root causes and corrective actions to be taken.

Event Description

When placing the filter, the legs did not expand.Had to go femoral to retrieve and place another.Once retrieved, they noticed a suture like string around legs of filter and material coming out of the sheath.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: RETRIEVABLE IVC FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12339357
• MDR Text Key: 268467649
• Report Number: 0001625425-2021-01067
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• Combination Product (y/n): N
• 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: 09/23/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11356485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other