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

Model Number 352506070E

Device Problems Device Damaged by Another Device (2915); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2022

Event Type  malfunction  

Manufacturer Narrative

The sample is not available for investigation.Customer provided an image.A follow-up report will be submitted once the image has been reviewed.

Event Description

During optionelite deployment via fem approach, the filter feet stripped the sheath completely causing the sheath to split (see attached photo).The pusher seemed to cause the filter feet to spread within the sheath which resulted in the failure.Filter was caught on sheath component, unsuccessfully deployed, and retrieved.It was noted that the filter cartridge was fully attached before deployment.Filter was not saved to return for evaluation.

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.A review of photos from the customer was performed and found liner around the filter retention hook.Most likely, when user advanced the filter during procedure, filter retention hook tore the liner from the sheath and got wrapped around the filter.This caused the filter to not open normally and the complaint was confirmed.Fi 2021-057 and capa c-2020-052 were initiated to investigate the root cause and corrective action of this issue.

Event Description

During optionelite deployment via fem approach, the filter feet stripped the sheath completely causing the sheath to split (see attached photo).The pusher seemed to cause the filter feet to spread within the sheath which resulted in the failure.Filter was caught on sheath component, unsuccessfully deployed, and retrieved.It was noted that the filter cartridge was fully attached before deployment.Filter was not saved to return for evaluation.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: OPTION ELITE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 15403397
• MDR Text Key: 305989947
• Report Number: 0001625425-2022-01084
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00886333217151
• UDI-Public: 00886333217151
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352506070E
• Device Catalogue Number: 352506070E
• Device Lot Number: 11420786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other