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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Thrombosis (2100); Anxiety (2328)

Event Date 10/31/2014

Event Type  Injury  

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.Vena cava occlusion is one of the potential complications cited in the ifu associated with this product.Per the ifu, candidates must not undergo filter retrieval if ¿at the time of retrieval procedure, based on venography and the physician¿s visual estimate, more than one (1) cubic centimeter of thrombus/embolus is present within the filter or caudal vena cava.¿.

Event Description

According to the notice received by way of a civil action complaint filed on (b)(6) 2016, the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2014.Approximately 23 days after implant, on or about (b)(6) 2014 the patient underwent a ct scan which revealed ¿1.Complete thrombosis of the inferior vena cava both above and below the ivc filter extending caudally from the level of the right renal vein.Thrombosis of the pelvic vessels as described.2.There is infiltration of the fat planes surrounding the venous structures in both retroperitoneum and pelvic side walls.This likely represents edema associated with relatively acute venous occlusion.¿ the filter could not be removed due to ivc thrombosis.The patient alleges ¿significant, life threatening injuries¿ as described above and the inability to remove the filter due to ivc thrombosis, which has led to ¿severe fear, stress, and anxiety.¿ argon¿s attorneys are attempting to gather 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: 6333003
• MDR Text Key: 67513969
• Report Number: 1625425-2017-00030
• 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: 02/15/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/15/2017
• 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