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Model Number 466P306AU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pulmonary Embolism (1498); Calcium Deposits/Calcification (1758); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100)
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Event Date 02/04/2019 |
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 injury and damage, including, but not limited to patient suffered from clotted inferior vena cava (ivc) filter and pulmonary embolism; significant amount of thrombus identified in the ivc filter causing limited flow in the inferior vena cava.The patient has 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, and pain and suffering, and other damages.There is currently no additional information available for review.The product was not returned for analysis and the sterile lot number provided is invalid; therefore, no device analysis nor device history record review could be performed.The trapease vena cava 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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.There is nothing in the information provided to suggest that the reported events are related to 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 damage, including, but not limited to patient suffered from clotted inferior vena cava (ivc) filter and pulmonary embolism; significant amount of thrombus identified in the ivc filter causing limited flow in the inferior vena cava.The patient has 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, and pain and suffering, and other damages.
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Manufacturer Narrative
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Complaint conclusion: as reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the filter was implanted due to hypercoagulable state with a history of pulmonary embolism (pe).The filter was placed in the inferior vena cava (ivc) below the level of the renal veins.The filter subsequently malfunctioned and caused injury and damage, including, but not limited to patient suffered from clotted inferior vena cava (ivc) filter and pulmonary embolism; significant amount of thrombus identified in the ivc filter causing limited flow in the inferior vena cava.Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc and post implant pulmonary embolism (pe).The patient also reports being hospitalized for an occlusive clot in the ivc filter, resulting in limited flow within the ivc.At this time, it was also determined that the patient suffered from a pulmonary embolus in the lower right lobe and segmental pulmonary arterial branches of the left lower lobe.As further indicated in the ppf, approximately a month post implant, the patient underwent iliocaval venogram with mechanical thrombectomy and angiojet thrombolysis and catheter-directed tpa.Approximately six months post implantation, the patient was hospitalized, and it was noted that there were calcifications of the aorta and iliac arteries.The filter remains implanted.The patient also reports frequent pelvic pain, only relieved when lying on the left side.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The trapease vena cava 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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Post procedure pulmonary embolism is a known potential adverse event associated with the use of the ivc filters.These events may be related to excessive clot burden from underlying patient specific factors.Vascular calcification is a known potential adverse event associated with the use of the ivc filters.Anxiety and pain do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to 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 damage, including, but not limited to patient suffered from clotted inferior vena cava (ivc) filter and pulmonary embolism; significant amount of thrombus identified in the ivc filter causing limited flow in the inferior vena cava.The patient has 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, and pain and suffering, and other damages.The following additional information was received per the patient¿s implant records: the filter was implanted due to hypercoagulable state with a history of pulmonary embolism (pe).The trapease filter was placed in the inferior vena cava (ivc) below the level of the renal veins.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately five years and seven months post implantation.The patient reports blood clots, clotting, and/or occlusion of the ivc and post implant pulmonary embolism (pe).The patient also reports being hospitalized for an occlusive clot in the ivc filter, resulting in limited flow within the ivc.At this time, it was also determined that the patient suffered from a pulmonary embolus in the lower right lobe and segmental pulmonary arterial branches of the left lower lobe.As further indicated in the ppf, approximately a month post implant, the patient underwent iliocaval venogram with mechanical thrombectomy and angiojet thrombolysis and catheter-directed tpa.Approximately six months post implantation, the patient was hospitalized, and it was noted that there were calcifications of the aorta and iliac arteries.The filter remains implanted.The patient will require lifelong monitoring of the filter to ensure that it does not fracture, perforate, migrate, or malfunction in some way, creating a life-threatening situation for the patient.The patient must now live with constant worry and anxiety about the state of health related to the filter.In addition, the patient continues to suffer from: frequent pelvic pain that has been experienced since the filter was deployed and is only relieved when lying on the left side.
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Search Alerts/Recalls
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