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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES OPTION RETRIEVABLE VENA CAVA FILTER RETRIEVABLE IVC FILTER Back to Search Results
Catalog Number UNKNOWN
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2011
Event Type  Injury  
Manufacturer Narrative

The device has not been returned for evaluation and no visual evidence 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 re-evaluated as needed.

 
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) 2011 by dr. (b)(6) at (b)(6) in (b)(6). The complaint alleges there was tilt, migration, and fracture post-implant which required complex removal. The filter was retrieved on (b)(6) 2015 by dr. (b)(6) at the (b)(6). (b)(6) attorneys are attempting to gather additional information.

 
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Brand NameOPTION RETRIEVABLE VENA CAVA FILTER
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 Key10272236
MDR Text Key198862711
Report Number1625425-2020-00396
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 07/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
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
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: 07/14/2020 Patient Sequence Number: 1
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