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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES INC. OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER Back to Search Results
Device Problem Occlusion Within Device (1423)
Patient Problems Pulmonary Embolism (1498); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative

The device has not been returned for evaluation and no images or videos have been provided of the filter in-vivo, so the complaint cannot be confirmed. If additional information is provided in the future, this issue will be reevaluated as needed.

 
Event Description

According to the notice received by way of a civil action complaint filed on (b)(6) 2018, the patient was prescribed and implanted with an option retrievable ivc filter on or about (b)(6) 2015 by dr. (b)(6) at (b)(6) hospital in (b)(6). No attempt has been made to retrieve the filter; therefore it remains implanted. The patient alleges breakthrough pulmonary embolism, and filter thrombosis post implant occurred. Further the patient states ¿the irretrievable filter subject plaintiff to risk of future and progressive filter failure including migration, fracture, embolization of a fracture, clotting, thrombosis and even death. ¿ argon¿s attorneys are attempting to gather additional information.

 
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Brand NameOPTION 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 Key7588766
MDR Text Key110706051
Report Number1625425-2018-00059
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 06/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2018
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

Patient TREATMENT DATA
Date Received: 06/11/2018 Patient Sequence Number: 1
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