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U.S. Department of Health and Human Services

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

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ARGON MEDICAL, INC. OPTION IVC FILTER RETRIEVABLE INFERIOR VENA CAVA FILTER Back to Search Results
Catalog Number 352506070E
Device Problems Fracture (1260); Material Twisted/Bent (2981)
Patient Problem No Code Available (3191)
Event Date 07/31/2013
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 november 29, 2018, the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2013 by dr. (b)(6). The patient had a scheduled retrieval procedure on or about (b)(6) 2013 performed by dr. (b)(6); the filter was not retrieved. The patient had another scheduled retrieval procedure on or about (b)(6) 2013 performed by dr. (b)(6); the filter was not retrieved. The complaint alleges that the filter has tilted, fractured, and that patient has undergone multiple retrieval surgeries. 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, INC.
1445 flat creek road
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL, INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
9036759321
MDR Report Key8285376
MDR Text Key134380179
Report Number1625425-2019-00010
Device Sequence Number1
Product Code DTK
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number352506070E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/29/2019 Patient Sequence Number: 1
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