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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
Catalog Number 352506070
Device Problems Difficult to Remove (1528); Malposition of Device (2616)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Anemia (1706); Perforation (2001); Renal Failure (2041); Thrombosis (2100); Loss of Vision (2139); Stenosis (2263); Diabetic Ketoacidosis (2364); Disability (2371); Coma (2417); Paraplegia (2448); Respiratory Failure (2484)
Event Date 12/03/2015
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¿, "death", "filter migration/movement", "incorrect positioning or orientation of the filter", "vena cava or other vessel injury or damage, including rupture or dissection, possibly requiring surgical repair or intervention", "thromboembolic events, including dvt, acute or recurrent pulmonary embolism or air embolism, possibly causing end organ infarction/damage/failure", 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.
 
Event Description
According to the notice received by way of a civil action complaint filed on november 17, 2017, the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2015 by dr. (b)(6) at (b)(6) medical center in (b)(6). The patient had a scheduled retrieval approximately 6 months later, on or about (b)(6) 2015 by dr. (b)(6) at (b)(6) medical center in (b)(6). The filter was unable to be retrieved due to filter thrombosis, breakthrough pulmonary embolism, embedment, tilting and perforation. Further, the patient alleges ¿stenosis, inability to retrieve device, paralysis of lower extremities, filter phlegmasia cerulean dolens, compartment syndrome, coma, blindness, bilateral compartment fasciotomy, chemical clot busting, thrombectomy, angioplasty of left common femoral vein and ivc, acute renal failure, dialysis, acute respiratory failure, diabetic ketoacidosis, anemia, shock, rhabdomyolysis, and inability to work. ¿.
 
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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 Key7137086
MDR Text Key95451173
Report Number1625425-2017-00171
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 other
Reporter Occupation Attorney
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number352506070
Device Lot NumberS37477
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 Received11/22/2017
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: 12/20/2017 Patient Sequence Number: 1
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