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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2017

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."vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring surgical repair or intervention", "thromboembolic events, including dvt, acute or recurrent pulmonary embolism or air embolism, possibly causing end organ infarction/damage/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".

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) 2012 by dr.(b)(6) at (b)(6) in (b)(6).The patient claims that they suffered a breakthrough pulmonary embolism post implant, on an unknown date which required ¿requiring pulmonary embolectomy¿ and found the filter ¿struts entered the lower pole of plaintiff¿s horseshoe kidney.¿ the patient had a scheduled retrieval approximately 5 years later, on or about (b)(6) 2017 by dr.(b)(6) at (b)(6) medical center in (b)(6); the physician was unable to retrieve the device.The patient underwent a second scheduled retrieval approximately 1 month later, on or about (b)(6) 2017 dr.(b)(6) at (b)(6) hospital in (b)(6).The filter was retrieved.(b)(6) 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: 7123105
• MDR Text Key: 95052984
• Report Number: 1625425-2017-00162
• 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: 12/15/2017

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: 11/17/2017
• Initial Date FDA Received: 12/15/2017
• 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): Required Intervention