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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Calcium Deposits/Calcification (1758); Perforation (2001)
Event Date 06/16/2017
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 re-evaluated as needed.
 
Event Description
According to the notice received by way of a civil action complaint filed on (b)(6) 2019, the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2017 by (b)(6).The complaint alleges tilt and perforation.The complaint specifically alleges ¿mild aortic calcification.¿ argon¿s attorneys are attempting to gather additional information.
 
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Brand Name
OPTION IVC FILTER
Type of Device
RETRIEVABLE 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 Key9911219
MDR Text Key189308397
Report Number1625425-2020-00255
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 Other
Type of Report Initial
Report Date 01/01/2005,03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number352506070E
Device Lot NumberQ1067800
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 03/06/2020
Initial Date FDA Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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