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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES INC. OPTION ELITE IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER Back to Search Results
Catalog Number 352506070E
Device Problems Difficult to Remove (1528); Material Perforation (2205); Device Damaged by Another Device (2915)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 11/07/2016
Event Type  Injury  
Manufacturer Narrative
No product or case images have been received related to this complaint, therefore, the complaint could not be confirmed. As such, a definitive root cause could not be determined for this issue. The tilt of the filter was likely due to improper centering at the time of implantation/deployment. When the hook is tilted severely, as with this case where the hook was reported to have been against the vena cava wall, retrieval can be especially difficult.
 
Event Description
The doctor was removing an option filter and the hook was embedded in the anterior wall. Used a cook retrieval set and tried some advanced techiques to retrieve the filter. It ended up perforating the ivc and the patient had to have it surgically removed. Patient had to be hospitalized. The filter was implanted in (b)(6) 2016.
 
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Brand NameOPTION ELITE 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 Key6148709
MDR Text Key61544459
Report Number1625425-2016-00094
Device Sequence Number1
Product Code DTK
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 12/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number352506070E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2016
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
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/06/2016 Patient Sequence Number: 1
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