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

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.

• Brand Name: OPTION ELITE RETRIEVABLE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12364709
• MDR Text Key: 268069395
• Report Number: 12364709
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352506100E
• Device Catalogue Number: 352506100E
• Device Lot Number: 11347150
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16425 DA
• Patient Weight: 30