Catalog Number 466P306X |
Device Problem
Occlusion Within Device (1423)
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Patient Problem
Thrombosis (2100)
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Event Date 04/21/2016 |
Event Type
Injury
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Manufacturer Narrative
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Please note that the event date is unknown but for reporting purposes the alert date of april 21, 2016 is being used.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.
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Event Description
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As reported via the legal department, notification of legal action was received involving four plaintiffs.Plaintiff number four (#4), underwent placement of a trapease filter, which subsequently malfunctioned.The device, inter alia, caused thrombosis of the vena cava and filter.As a result of these malfunctions, he suffered life-threatening injuries and damages and required extensive medical care and treatment, including multiple medical procedures.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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Manufacturer Narrative
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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 which subsequently malfunctioned.The device, inter alia, caused thrombosis of the vena cava and filter.As a result of these malfunctions, he suffered life-threatening injuries and damages and required extensive medical care and treatment, including multiple medical procedures.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 or within the vessel does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication and occurs in approximately(b)(4) of all patients.As such, it is addressed in the product¿s instructions for use (ifu).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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Search Alerts/Recalls
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