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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
Lot Number Q10882113
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Thrombosis (2100)
Event Date 06/06/2017
Event Type  Injury  
Manufacturer Narrative

At this time, there have been no samples or visual evidence returned for evaluation; therefore, no corrective action is possible. If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.

 
Event Description

Subject is a (b)(6) year old female a history of stroke within the previous 30 days, gfr > 60, current malignancy and a current dvt from the mid-femoral vein to the calf veins. She has a past history of resolved bilateral segmental pe, rle dvt limited to below the popliteal vein and lle dvt of the common iliac vein. Subject was consented into preserve on (b)(6) 2017 and had an option¿ elite retrievable vena cava filter placed on same day, for a contraindication to anticoagulation due to upcoming spinal surgery. She was discharged from hospital to a skilled nursing facility on (b)(6) 2017 with a tentative plan for initiation of therapeutic anticoagulation 3 weeks after spinal surgery. Her postoperative course was complicated by a new diagnosis of heparin induced thrombocytopenia, which resulted in a caval occlusion seen on ct on (b)(6) 2017. The same examination revealed a new iliac dvt. Subject was treated with argatroban anticoagulation and scheduled for thrombectomy and filter removal. A procedure planning ultrasound on (b)(6) 2017 confirmed the iliac dvt and documented it extended caudally into both legs, beyond the extent that was previously imaged on ct. The subject remained hospitalized until (b)(6) 2017 while transitioning from argatroban to coumadin anticoagulation therapy. At the 1-month post-retrieval visit on (b)(6) 2017, the subject still had left lower leg edema, but the ultrasound on (b)(6) 2018 demonstrated that all dvts (caval, iliac, femoral, etc. ) had resolved. The subject remains on indefinite coumadin anticoagulation therapy, due to her medical history.

 
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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 Key9459776
MDR Text Key175210885
Report Number1625425-2019-00307
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK133243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type STUDY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/01/2005,11/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device LOT NumberQ10882113
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
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 Received11/15/2019
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 12/12/2019 Patient Sequence Number: 1
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