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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
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ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE VENA CAVA FILTER Back to Search Results
Model Number 352506070E
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 02/12/2024
Event Type  Injury  
Event Description
The reporter indicated option filter placed (b)(6) 2014 has, in recent ct images, shown to exhibit a fractured strut.One strut appears to be in the aorta, another appears to be imbedded into bone.The fractured strut appears to be extravascular.Images are available.
 
Manufacturer Narrative
The device was not returned for analysis.Images were provided.Investigation including root cause analysis is in progress.A supplemental mdr will be submitted upon investigation completion.
 
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Brand Name
OPTION ELITE RETRIEVABLE VENA CAVA FILTER
Type of Device
OPTION ELITE
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
kelly mayer
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key18872349
MDR Text Key337290718
Report Number0001625425-2024-00958
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00886333217151
UDI-Public00886333217151
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/10/2024
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? Yes
Device Operator Health Professional
Device Model Number352506070E
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/14/2024
Initial Date FDA Received03/11/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
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