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Catalog Number 466P306X |
Device Problem
Unintended Movement (3026)
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Patient Problem
Stenosis (2263)
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Event Date 07/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter occupation: other, senior counsel, litigation.Date of event: please note that the exact event date is unknown and the event date is the complaint awareness date.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused tilt and stenosis of the filter.The indication for the filter implant has 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 trapease ivc 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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Stenosis is an abnormal narrowing of a vessel; this does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.The timing and mechanism of the reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported tilt and stenosis could not be confirmed or further clarified.There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.Please note that this is the initial report for this product.
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Event Description
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As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilt and stenosis of the filter.As a direct and proximate result of these malfunctions, 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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