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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION RETRIEVABLE VANA CAVA FILTER SYSTEM RETRIEVABLE IVC FILTER
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ARGON MEDICAL DEVICES OPTION RETRIEVABLE VANA CAVA FILTER SYSTEM RETRIEVABLE IVC FILTER Back to Search Results
Catalog Number 352506070
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Perforation (2001)
Event Date 07/20/2010
Event Type  Injury  
Manufacturer Narrative

The device is indicated as unavailable for evaluation. Without the device or any images in-vivo to review, the complaint cannot be confirmed, and the root cause cannot be determined. If additional information is received in the future, a follow-up report will be provided.

 
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) 2010 by dr. (b)(6) at (b)(6). The complaint alleges there was migration and perforation post-implant. The filter remains implanted today. Argon¿s attorneys are attempting to gather additional information.

 
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Brand NameOPTION RETRIEVABLE VANA CAVA FILTER SYSTEM
Type of DeviceRETRIEVABLE IVC FILTER
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key10322030
MDR Text Key200404057
Report Number1625425-2020-00440
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
PMA/PMN NumberK081410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 07/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352506070
Device LOT NumberS31002
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/02/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/24/2020 Patient Sequence Number: 1
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