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

Device Problems Entrapment of Device (1212); Fracture (1260)

Patient Problems Tissue Damage (2104); Injury (2348); Foreign Body In Patient (2687)

Event Date 01/12/2016

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¿, "vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring surgical repair or intervention" 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 (b)(6) 2017, the patient was prescribed and implanted with an option retrievable ivc filter on or about (b)(6) 2010 by dr.(b)(6) at (b)(6) hospital in (b)(6).The patient had a scheduled removal approximately 6 years later, on or about (b)(6) 2016 by dr.(b)(6).The filter was embedded in the wall of the vena cava, but it was dissected free of the ivc wall using endobronchial forceps.During the removal, the filter had fractured and the fractured piece was unable to be retrieved.The patient alleges ¿significant injuries¿ including the fracture of the retrieval hook which made the filter strut un-retrievable, which the patient alleges place them at increased risk of additional fracture, perforation and penetration.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: 6530636
• MDR Text Key: 74163626
• Report Number: 1625425-2017-00062
• 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: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• 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: 04/04/2017
• 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