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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION RETRIEVABLE VANA CAVA FILTER SYSTEM; OPTION ELITE
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ARGON MEDICAL DEVICES OPTION RETRIEVABLE VANA CAVA FILTER SYSTEM; OPTION ELITE Back to Search Results
Model Number 352506070
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Stenosis (2263)
Event Date 04/15/2022
Event Type  malfunction  
Event Description
Angiotech option was implanted, vena cava filter on 2010.Ivc evaluated by ct abdomen and pelvis without contrast on 2022 posterior prongs out of lumen, abutting l3 vertebral body, aorta and intestine.Vc stenosis at filter.Migration of ibc outside lumen.Plan: on 2022 retrieval of inferior vena cava filter, possible venogram with possible venoplasty, possible aortogram with possible angioplasty or stenting.Angiotech option implanted, inferior vena cava filter.
 
Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
 
Event Description
Angiotech option was implanted, vena cava filter on 2010.Ivc evaluated by ct abdomen and pelvis without contrast on 2022 posterior prongs out of lumen, abutting l3 vertebral body, aorta and intestine.Vc stenosis at filter.Migration of ibc outside lumen.Plan: on 2022 retrieval of inferior vena cava filter, possible venogram with possible venoplasty, possible aortogram with possible angioplasty or stenting.Angiotech option implanted, inferior vena cava filter.
 
Manufacturer Narrative
The lot number was not provided, so the manufacturing and inspection records could not be reviewed.After second notification, according to the customer, the sample was unavailable to be returned for evaluation.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence this complaint could not be confirmed.The complaint was closed.No corrective action is required at this time.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.
 
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Brand Name
OPTION RETRIEVABLE VANA CAVA FILTER SYSTEM
Type of Device
OPTION ELITE
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key14743161
MDR Text Key294407008
Report Number0001625425-2022-01027
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number352506070
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2022
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
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