MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER; RETRIEVABLE IVC FILTER

Model Number UNKNOWN

Device Problems Coagulation in Device or Device Ingredient (1096); Entrapment of Device (1212); Migration (4003)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

Device not available for evaluation.Without such evidence to review, complaint cannot be confirmed.If additional information is provided in the future, follow-up report will be submitted.

Event Description

According to the notice received by way of a civil action complaint, the patient was prescribed and implanted with an option vena cava filter on or about (b)(6) 2017 by doctor (b)(6) at (b)(6) hospital in (b)(6).Additionally, patient was prescribed and implanted with an option elite vena cava filter on or about (b)(6) 2018 by doctor (b)(6) at (b)(6) hospital in (b)(6).The complaint alleges there was filter thrombosis post implant and tilt post implant.The filter(s) was/not retrieved, despite three failed attempted retrievals.Argon's attorneys are attempting to gather additional information.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: RETRIEVABLE IVC FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: gina liu ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 11858632
• MDR Text Key: 251895842
• Report Number: 0001625425-2021-00936
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: No
• 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