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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. OPTION ELITE RETRIEVABLE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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ARGON MEDICAL DEVICES, INC. OPTION ELITE RETRIEVABLE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 352506100E
Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problems Hypoxia (1918); Pulmonary Dysfunction (2019); Tachycardia (2095); Device Embedded In Tissue or Plaque (3165)
Event Date 08/05/2021
Event Type  Malfunction  
Event Description

While removing the dilator from the option elite ivc filter deployment sheath, the distal marker of the dilator came off against the sheath tip and embolized to the patient's right lung. The dilator removal was done over an amplatz wire and in a smooth fashion without resistance or manipulation. This embolized object represents an approximately 2. 5 mm circular, thin metallic marker that would be near impossible to retrieve endovascularly in the physician's opinion. Additionally, the patient was tachycardic, hypoxic, and had significant pulmonary injury related to covid. Any attempt at endovascular retrieval would have resulted in more harm to the patient than retaining the metallic marker. Patient is also not a candidate for open surgical retrieval of the marker. This tiny marker is inconsequential to the patient's pulmonary function per physician's opinion. Our representative was notified of the event and came to the facility to take photos of the sheath. The device was not released to the representative and at this time status regarding releasing it is pending. The representative came to the facility and took photos of the device. The device was not released to the representative.

 
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Brand NameOPTION ELITE RETRIEVABLE VENA CAVA FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek rd
athens TX 75751
MDR Report Key12364709
MDR Text Key268069395
Report Number12364709
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 08/19/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number352506100E
Device Catalogue Number352506100E
Device LOT Number11347150
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/19/2021
Event Location Hospital
Date Report TO Manufacturer08/25/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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