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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER RETRIEVABLE IVC FILTER Back to Search Results
Model Number 352506070E
Device Problems Complete Blockage (1094); Difficult to Remove (1528)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 10/12/2017
Event Type  Injury  
Manufacturer Narrative
The sample device is indicated as unavailable for evaluation. Without the sample device or any visual images to review, the complaint cannot be confirmed. If additional information is received for investigation, 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 elite vena cava filter on or about (b)(6) 2017 by dr. (b)(6) at (b)(6) medical center. The complaint alleges there was filter thrombosis post-implant, embedment, and the filter was unable to be removed after two (2) attempted retrieval surgeries. Argon¿s attorneys are attempting to gather additional information.
 
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Brand NameOPTION ELITE 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 Key10113050
MDR Text Key193605983
Report Number1625425-2020-00331
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K133243
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 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2017
Device Model Number352506070E
Device Catalogue Number352506070
Device Lot NumberQ731554
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 Manufactured06/30/2015
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: 06/02/2020 Patient Sequence Number: 1
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