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Catalog Number 466P306X |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 06/01/2021 |
Event Type
Injury
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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 portal vein thrombosis (pvt).The indication for the filter implant, procedural details and medical history of the patient 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.Portal vein thrombosis was reported, however with the limited information provided the event could not be further clarified.Blood clots, clotting, and occlusion of the device or vasculature do not indicate a device malfunction.With the limited information provided a clinical conclusion could not be made, however, patient, vessel characteristics and pharmacological factors may have contributed to these events.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.
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Event Description
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As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to physical and emotional damages from portal vein thrombosis (pvt) and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.
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Search Alerts/Recalls
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