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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 Problems Filter (816); Malposition of Device (2616); Tip (3123)
Patient Problem Injury (2348)
Event Date 08/18/2017
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. ¿device breakage or failure or inability to retrieve implanted device as described in ifu, possibly requiring another intervention or treatment modality to complete procedure¿, "vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring surgical repair or intervention" and "injury or damage to organs adjacent to vena cava, possibly requiring surgical repair or intervention" are potential complications cited in the ifu associated with this product. In the optional procedure for filter retrieval section of the ifu, it states: ¿if the filter is retrieved, it should be done within 175 days following implant. ¿ this device can remain permanently implanted.

 
Event Description

According to the notice received by way of a civil action complaint filed on september 8, 2017, the patient was prescribed and implanted with an option retrievable ivc filter on or about (b)(6) 2010 by dr. (b)(6) at (b)(6). The patient states they were never considered for revision or removal of the device by any medical professional. Further, the patient had a scheduled ct scan of the abdomen performed on or about (b)(6) 2017 at (b)(6) which allegedly showed ¿the tip of the filters¿ catheter was at the inferior edge of the left renal. The scan showed tilting of the filter with the tip being close to the posterior wall. Although there was no fracture, one of the struts of the filter extends beyond the lumen and was near the aorta. Furthermore, there is protrusion of an anterior strut close to the duodenum. ¿ the patient alleges as a result of the ct scan they were notified the filter ¿malfunctioned. ¿ the patient alleges they are at a high risk of suffering ¿potential future injuries¿ which has led to the patient to suffer ¿mental anguish and psychological trauma. ¿ 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 Key7004618
MDR Text Key91186886
Report Number1625425-2017-00146
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 11/06/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2017
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 Received10/08/2017
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: 11/06/2017 Patient Sequence Number: 1
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