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

Catalog Number 352506070E

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

The device is currently under evaluation.A follow-up report will be submitted when the evaluation is complete.

Event Description

Customer reported an in-situ fracture of option ivc filter prior to retrieving the filter.Filter and broken strut were successfully retrieved.Sample available.(implanting surgeon dr.(b)(6)).

Manufacturer Narrative

The initial report for this complaint was sent in 2018.The returned sample device was forwarded to the supplier facility, (b)(4), for further evaluation.(b)(4) provided findings in january 2020.Their findings indicate as follows "one strut fracture initiated on a sidewall at an inclusion.Presence of an inclusion at the surface of a stressed section of filter may be the potential root cause for the fracture.One strut fracture initiated at od/sidewall and propagated to opposite sidewall.Post-damage of the fracture surface due to rubbing prevented identification of the root cause.Other strut fractures show evidence of overload and tool marks that are consistent with handling during retrieval of the filter".The filter was implanted for over 2 years.It is believed that the device ifu may not have been followed when retrieving the device.It cautions "excessive force should not be used to retrieve the filter".Severe mechanical damage found on the filter suggest tool damage during handling of the component during retrieval.Overload fracture is consistent with handling during retrieval of the filter.Based on (b)(4) investigation findings, the product issue was most likely due to user use.Since the issue could not be traced back to design or manufacturing defect, a corrective action will not be required at this time.H3 other text : placeholder.

• Brand Name: OPTION IVC FILTER
• Type of Device: RETRIEVABLE INFERIOR VENA CAVA FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 7489477
• MDR Text Key: 107578552
• Report Number: 1625425-2018-00040
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): Y
• PMA/PMN Number: K133243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352506070E
• Device Lot Number: Q1194732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention