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

Catalog Number 352506070

Device Problems Fracture (1260); Material Fragmentation (1261); Malposition of Device (2616)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Emotional Changes (1831); Pain (1994); Perforation (2001); Device Embedded In Tissue or Plaque (3165)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

A review of the device history record was performed and no concerns were found.The device has not been returned for evaluation and no images or videos have been provided of the filter in-vivo, so the complaint cannot be confirmed.If additional information is provided in the future, this issue will be reevaluated as needed.

Event Description

According to the notice received by way of a civil action complaint filed on may 16, 2018, the patient was prescribed and implanted with an option retrievable ivc filter on or about (b)(6) 2011 by dr.(b)(6) at (b)(6) medical center in (b)(6).The patient had a scheduled retrieval approximately 6 years later, on or about (b)(6) 2017 by dr.(b)(6) at (b)(6), main campus in (b)(6).The filter was partially retrieved and the plaintiff alleges the filter, tilted, embedded, fractured and perforated as well as ¿incomplete removal of the ivc filter with one filter leg and two filter arms remaining in plaintiff¿s body.Interaction of the filter struts with organs, blood vessels, and structures, including limitation the aorta, duodenum and spine.The retained struts subject plaintiff to the ongoing risk of complications and injury.Plaintiff has also suffered noneconomic damages including without limitation pain, suffering, emotional distress and loss of enjoyment of life.¿ argon¿s attorneys are attempting to gather additional information.

• 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
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 7636535
• MDR Text Key: 112281282
• Report Number: 1625425-2018-00071
• 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: Attorney
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352506070
• Device Lot Number: S34798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2018
• 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): Other