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Model Number 466FXXXX
Device Problem Unintended Movement (3026)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/30/2021
Event Type  Injury  
Manufacturer Narrative
It was reported that a patient underwent placement of an optease vena cava filter. The information provided indicated that the filter subsequently malfunctioned and caused tilting of the ivc filter 14 degrees. The indication for the filter implant, procedural details and medical history of the patient have not been provided and there is currently no additional information available for review. The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed. The optease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated. The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart. Post implant imaging has not been provided. Without the procedural films or post-placement imaging and the limited information provided, the report of tilt could not be confirmed or further clarified. Additionally, the timing and mechanism of the filter tilt is unknown. Ivc filter tilt has been associated with operator technique, vessel characteristics, specifically asymmetry and tortuosity. Given the limited information currently available for review, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken. Should additional information become available, the file will be updated accordingly.
Event Description
As reported by the legal department, the patient underwent placement of the optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilting of the ivc filter 14 degrees. As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.
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Brand Name466FXXXX
Manufacturer (Section D)
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
14201 nw 60 avenue
miami lakes FL 33152
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key12240776
MDR Text Key264069852
Report Number1016427-2021-05149
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/28/2021 Patient Sequence Number: 1