As reported via the legal department, notification of legal action was received involving four plaintiffs.Plaintiff number one (#1) underwent placement of a trap ease permanent vena cava filter.The device subsequently malfunctioned and caused, inter alia, thrombosis of the inferior vena cava.As a result of the malfunction, the patient has suffered life-threatening injuries and damages and required extensive medical care and treatment.The plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.No additional information is available.
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As reported via the legal department, notification of legal action was received.One plaintiff underwent placement of a trapease permanent vena cava filter.The device subsequently malfunctioned and caused, inter alia, thrombosis of the inferior vena cava.As a result of the malfunction, the patient has suffered life-threatening injuries and damages and required extensive medical care and treatment.The plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.No additional information is available.The device remains implanted in the patient and is not available for inspection.Manufacturing records (dhr) could not be reviewed, as the product catalog and lot number are not available.The purpose of a vena cava filter is to catch thrombus (a clot of blood formed within a blood vessel) from the lower extremities as it travels along normal blood flow patterns up towards the heart.Thrombus in the filter does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication and occurs in approximately 3.6 to 11.2% of all patients.As such, it is addressed in the product¿s instructions for use.Factors that may contribute to thrombus may include patient factors, pharmacological and lesion characteristics.Based on the limited information available for review, there is no indication of a design or manufacturing related cause for this event.Therefore, no corrective action will be taken at this time.Should additional information become available, the file will be updated accordingly.
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