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 Cardiopulmonary Arrest (1765); Death (1802); Occlusion (1984); Thromboembolism (2654)

Event Date 09/16/2015

Event Type  Death  

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.Pulmonary embolism 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 (b)(6)he patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) by dr.(b)(6) at (b)(6).The patient died approximately 3 weeks later, on or about (b)(6) 2015 due to but not limited to ¿cardiopulmonary arrest resulting from bilateral pulmonary thromboemboli which completely occluded the main, right, and left pulmonary arteries.¿ further it is alleged that ¿an autopsy revealed the filter ¿had failed to filter or catch blood clots/thrombi traveling to decedent¿s heart and lungs.¿ argon¿s 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: 6876727
• MDR Text Key: 86640042
• Report Number: 1625425-2017-00130
• 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: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• 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: 08/22/2017
• 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): Death