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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 Break (1069); Migration or Expulsion of Device (1395); Difficult to Remove (1528)
Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)
Event Date 06/02/2020
Event Type  Injury  
Manufacturer Narrative

The device is indicated as available for evaluation. As of the date of this report, the device has not yet been returned. A follow-up report will be provided when the device has been received and reviewed.

 
Event Description

Argon option elite ivc retrievable filter placed as an inpatient 2019. Intention to remove in future. Returned after follow up 2020 as an outpatient for removal device had fractured with strut broke in tow pieces large piece migrating through caval wall over time and affecting l2 vertebral body second broken piece embolized to the lung and could not be retrieved the main body was retrieved. The patient has back pain.

 
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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 Key10359975
MDR Text Key201507676
Report Number1625425-2020-00453
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
PMA/PMN NumberK133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number352506070E
Device Catalogue Number352506070E
Device LOT Number11258733
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
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: 08/03/2020 Patient Sequence Number: 1
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