Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION RETRIEVABLE VENA CAVA FILTER; RETRIEVABLE IVC FILTER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARGON MEDICAL DEVICES OPTION RETRIEVABLE VENA CAVA FILTER; RETRIEVABLE IVC FILTER Back to Search Results
Catalog Number UNKNOWN
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Migration (4003)
Patient Problem Perforation (2001)
Event Date 02/27/2015
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.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) 2015 by dr.(b)(6)at (b)(6).The complaint alleges there was embedment, tilt, and perforation post-implant as well as a failed retrieval attempt on (b)(6) 2016 by dr.(b)(6) at (b)(6).The filter remains implanted today.Argon¿s attorneys are attempting to gather additional information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OPTION RETRIEVABLE VENA CAVA FILTER
Type of Device
RETRIEVABLE 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 Key10364424
MDR Text Key201685214
Report Number1625425-2020-00461
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K081410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
-
-