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Model Number 466P306X |
Device Problem
Failure to Align (2522)
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Patient Problems
Coagulation Disorder (1779); Occlusion (1984)
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Event Date 11/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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The catalog number is unknown, if received it will be provided.Complaint conclusion: 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 occlusion.The indication for the filter implant, patient medical history and procedural details have not been provided.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 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.Occlusion of the filter was reported, however with the limited information provided the event could not be further clarified, it is unknown if it was a stenotic or thrombotic event.Blood clots, clotting and/or occlusive thrombosis within the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.With the limited information provided it is not possible to draw a conclusion between the events and the device.There is nothing in the information provided to suggest that there is a malfunction in 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 brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: tilt and occlusion.
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Manufacturer Narrative
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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 occlusion.The patient reported becoming aware of tilt, blood clots, clotting, and/or occlusion of the ivc approximately thirteen years and three months post implant.The patient also reports anxiety and worry.According to the operative report the indication for the filter placement was prophylactically for high risk of pulmonary embolism prior to bariatric surgery for morbid obesity.The filter was laced via the left femoral vein and deployed at the approximate body of l3.The patient reportedly tolerated the procedure well.The patient underwent gastric bypass six days post filter implant.The patient also has a history of aortic valve stenosis, hypertensive heart disease, factor v leiden mutation, mitral valve stenosis and coronary atherosclerosis.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 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.Occlusion of the filter was reported, however with the limited information provided and no imaging available for review the event could not be further clarified, it is unknown if it was a stenotic or thrombotic event.Blood clots, clotting and/or occlusive thrombosis within the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient (factor v leiden mutation), pharmacological and lesion characteristics.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing in the information provided to suggest that there is a malfunction in 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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Search Alerts/Recalls
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