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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 Problems Migration or Expulsion of Device (1395); Material Twisted/Bent (2981)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation (2001)
Event Date 11/29/2016
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) 2018, the patient was prescribed and implanted with an option retrievable elite ivc filter on or about (b)(6) 2016 by dr (b)(4) at (b)(6 ). The patient later underwent two scheduled retrieval procedures on or about (b)(6) 2016 and (b)(6) 2016, both performed by dr (b)(6) at (b)(6). The physician was unable to retrieve the filter on both occasions due to embedment, tilt, and perforation. Allegedly, a leg of the filter appears to be bent as a result of attempting retrieval. 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 Key8088074
MDR Text Key127852223
Report Number1625425-2018-00178
Device Sequence Number1
Product Code DTK
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received10/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/19/2018 Patient Sequence Number: 1
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