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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES INC. OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER Back to Search Results
Device Problem Complete Blockage (1094)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation (2001)
Event Type  Injury  
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.

 
Event Description

According to the notice received by way of a civil action complaint filed on (b)(6) 2019, the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2015 by dr. (b)(6) at (b)(6) medical center in (b)(6). The complaint alleges that there is embedment and perforation and filter thrombosis post implant. Argon¿s attorneys are attempting to gather additional information.

 
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Brand NameOPTION IVC FILTER
Type of DeviceRETRIEVABLE INFERIOR VENA CAVA FILTER
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
1445 flat creek road
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key8545102
MDR Text Key142929683
Report Number1625425-2019-00099
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,04/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2019
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received04/04/2019
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 04/24/2019 Patient Sequence Number: 1
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