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

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395)

Patient Problems Chest Pain (1776); Embolism (1829); Respiratory Distress (2045)

Event Date 03/31/2016

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.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", "thromboembolic events, including dvt, acute or recurrent pulmonary embolism or air embolism, "vena cava stenosis or occlusion", and "vasospasm or decreased/impaired blood flow" are 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 march 27, 2017 the patient was prescribed and implanted with an option retrievable ivc filter on or about (b)(6) 2011 by dr.(b)(6) at (b)(6).The patient presented to (b)(6) medical center emergency department on (b)(6) 2016 complaining of chest pain and shortness of breath.A ct scan was done which allegedly showed a ¿bilateral acute pulmonary embolism and that the filter was tilted, eroded into the lumen and migrated.Further, the patient alleges ¿the discharge summary states that the displaced ivc filter could be the source of the pulmonary embolism itself.¿ the patient alleges significant injuries including an embedded filter, pulmonary embolism and filter migration.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: 6519124
• MDR Text Key: 73611576
• Report Number: 1625425-2017-00056
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• 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: 03/29/2017
• 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