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

Lot Number Q1012062

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 02/17/2017

Event Type  Injury  

Event Description

Ivc filter deployed upside down.

• Brand Name: OPTION ELITE VENA CAVA FILTER
• Type of Device: IVC FILTER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 5151 headquarters drive; ste 210; plano TX 75024
• MDR Report Key: 6360636
• MDR Text Key: 68481503
• Report Number: MW5068123
• Device Sequence Number: 1
• Product Code: DTK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Lot Number: Q1012062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 62