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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES OPTION ELITE VENA CAVA FILTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 03/24/2011
Event Type  Injury  
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) 2011 by dr. (b)(6)at (b)(6) hospital & medical center in (b)(6). The complaint alleges there was perforation. The filter was not retrieved. Argon¿s attorneys are attempting to gather additional information.
 
Manufacturer Narrative
Sample is unavailable for evaluation. Without such evident to review, the complaint cannot be confirmed. If additional information is provided in the future, a follow-up report will be submitted.
 
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Brand NameOPTION ELITE VENA CAVA FILTER
Type of DeviceOPTION ELITE
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key12925594
MDR Text Key282200769
Report Number0001625425-2021-01192
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/03/2021 Patient Sequence Number: 1
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