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

Catalog Number 352506070E

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 05/19/2015

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.

Event Description

According to the notice received by way of a civil action complaint filed on (b)(6) 2018, the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2015 by dr.(b)(6) at (b)(6) memorial healthcare in (b)(6).The patient had a scheduled retrieval approximately 17 months later, on or about (b)(6) 2016 by dr.(b)(6).The physician was unable to retrieve the filter due to filter thrombosis post implant and the patient further alleges ¿occlusion of filter leading to severe collateralization around the filter and stenosis up to level of atrium.¿ 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: 7471365
• MDR Text Key: 106835230
• Report Number: 1625425-2018-00038
• 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: 04/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 352506070E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2018
• 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