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

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem Pulmonary Embolism (1498)

Event Date 01/13/2016

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.¿device breakage or failure or inability to retrieve implanted device as described in ifu, possibly requiring another intervention or treatment modality to complete procedure¿, "vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring surgical repair or intervention", "filter migration/movement", "respiratory insufficiency or failure" and "injury or damage to organs adjacent to vena cava, possibly requiring surgical repair or intervention" are potential complications cited in the ifu associated with this product.In the optional procedure for filter retrieval section of the ifu, it states: ¿if the filter is retrieved, it should be done within 175 days following implant.¿ in this case, retrieval was attempted after 175 days following implant.

Event Description

According to the notice received by way of a civil action complaint filed on march 14, 2017, the patient was prescribed and implanted with an option retrievable ivc filter on or about sometime in the year 2009.The patient had a scheduled removal approximately 5 years later on or about (b)(6) 2014.The physician(s) were unable to retrieve the filter.On or about (b)(6) 2016 the patient was diagnosed with bilateral pulmonary embolism and found the filter had migrated to the right pulmonary artery.The patient alleges that the implanted filter poses numerous risks, including that the filter it is not functioning as intended to prevent future pulmonary embolisms, the filter could further migrate, fracture or perforate the vena cava or surrounding vital organs or spinal column, and stress, fear 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: 6474420
• MDR Text Key: 72182912
• Report Number: 1625425-2017-00044
• 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: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• 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
• Date Manufacturer Received: 03/17/2017
• 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