MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION RETRIEVABLE VANA CAVA FILTER SYSTEM

Model Number 352506070

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Perforation (2001)

Event Date 01/06/2012

Event Type  Injury  

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) 2012 by dr.(b)(6)at (b)(6) hospital in (b)(6).The complaint alleges there was perforation.The filter was not retrieved.Argon¿s attorneys are attempting to gather additional information.

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.

• Brand Name: OPTION RETRIEVABLE VANA CAVA FILTER SYSTEM
• Type of Device: OPTION RETRIEVABLE VANA CAVA FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 12892895
• MDR Text Key: 281415021
• Report Number: 0001625425-2021-01161
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081410
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/01/2014
• Device Model Number: 352506070
• Device Lot Number: S36852
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other