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

Catalog Number 352506070E

Device Problems Fracture (1260); Material Fragmentation (1261); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Injury (2348); Cardiac Perforation (2513); Device Embedded In Tissue or Plaque (3165)

Event Date 10/17/2015

Event Type  malfunction  

Manufacturer Narrative

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.¿device breakage or failure or inability to retrieve implanted device as described in ifu, possibly requiring another intervention or treatment modality to complete procedure¿ is one of the potential complications cited in the ifu associated with this product.

Event Description

According to the notice received by way of a civil action complaint filed on march 15, 2018, the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2015 by dr.(b)(6) at (b)(6) hospital in (b)(6).The patient had a scheduled retrieval approximately 5 months later, on or about (b)(6) 2016 by dr.(b)(6).The physician was unable to retrieve the filter due to tilt and embedment and the filter was found to have fractured in which the fractured pieces allegedly migrated to the patient right atrium of his heart.The patient had a second scheduled retrieval approximately 1 week later, on or about (b)(6) 2016 by drs.(b)(6) at (b)(6) hospital in (b)(6).The pathology report indicated the ¿filter consisted of multiple loose wires.¿ the patient underwent retrieval of the fractured pieces 1 day later, on or about (b)(6) 2016 by drs.(b)(6).One (1) filter fragment was retrieved and it was later discovered by chest x-ray that 2 additional filter fragments remain in the right atrium of the patient¿s heart.The patient alleges ¿significant injuries, including, but not limited to, the embedment of the filter¿s retrieval hook, tilt of the filter, migration of the filter, fracture of the filter, perforation of the vena cava by the filter, perforation of the plaintiff¿s heart by the filter, damage to the plaintiff¿s vena cava, heart, and other organs, multiple retrieval surgeries, the need for future surgeries to retrieve fractured pieces of the option elite.¿.

• 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: 7442309
• MDR Text Key: 106404087
• Report Number: 1625425-2018-00033
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352506070E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2018
• 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