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

Model Number 352506070E

Device Problem Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

Sample was returned for evaluation.A follow-up report will be submitted once the investigation has been completed.

Event Description

Filter never deployed, legs were caught together by plastic.

Event Description

Filter never deployed, legs were caught together by plactic.

Manufacturer Narrative

A review of the sample found delamination of the sheath ptfe liner, confirming the complaint.Capa 1026 was initiated to investigate root causes for the filter getting caught in the sheath and/or scraping off the sheath lining during filter deployment.The investigation found the interaction between the sharp filter features (legs) with the sheath lining causes damage to the sheath lining during filter deployment.Corrective actions to modify sheath lining material selection and/or manufacturing processes to improve device performance are currently in progress.

• 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: 12137574
• MDR Text Key: 262896979
• Report Number: 0001625425-2021-01018
• 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: 08/03/2021

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: 05/13/2024
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11368426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other