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Model Number 466FXXXX |
Device Problem
Unintended Movement (3026)
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Patient Problems
Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/30/2021 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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