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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 352506070E
Device Problems Fracture (1260); Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Type  malfunction  
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", "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. 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 november 15, 2017, the patient was prescribed and implanted with an option retrievable ivc filter on or about (b)(6) 2012 by dr. (b)(6) at (b)(6) hospital in (b)(6). According to the patient, no attempt to retrieve the filter has been made but the filter was allegedly found to have migrated and fractured; therefore, the filter remains implanted. 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 Key7137071
MDR Text Key95853365
Report Number1625425-2017-00166
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? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number352506070E
Device Lot NumberS39443
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 Received11/21/2017
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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