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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); Aneurysm (1708); Coagulation Disorder (1779); Occlusion (1984)
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Event Date 03/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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As reported, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, post-implant pulmonary embolism.As a direct and proximate result of these malfunctions, the patient 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 device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The inferior vena cava (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 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.There are possible patient and pharmacological factors that may have contributed to the reported event.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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 team, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, post-implant pulmonary embolism.As a direct and proximate result of these malfunctions, the patient 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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The exact event date is unknown.Unknown 6 french introducer, unknown needle,
unknown wire.The implant date was confirmed to be accurate.Additional information is pending and will be submitted within 30 days upon receipt.
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Event Description
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As reported by the legal team, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, post-implant pulmonary embolism.As a direct and proximate result of these malfunctions, the patient 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 medical records: patient had a history of pulmonary embolism with contraindication to anticoagulant therapy.The filter was deployed at the infrarenal level.Approximately 2 years and 1 month post implantation, patient underwent a computerized topography (ct) scan.The impression from that scan were that there was a filling defect in the medial right lower lobe pymonary artery suggesting pulmonary embolus of uncertain age.Parenchymal calcification, small cavitary lesion in the superior segment of the right lower lobe of a wedge-shaped consolidation were noted.Right lower lobe hilar adenopathy mild thoracic aortic aneurysm, and mild right lower lobe bronchiectasis were also noted.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 3 years and 1 month post implantation.The patient reports blood clots, clotting, and/or occlusion of the ivc, and device unable to be retrieved but no removal attempt has been made.The patient also reports suffering from pain, being sick and unable to walk or bear weight on right leg for a week, and anxiety.
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Manufacturer Narrative
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Correction to (product code).
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Manufacturer Narrative
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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 injury and damages to the patient, including, but not limited to, post-implant pulmonary embolism.The patient also reports blood clots, clotting, and/or occlusion of the ivc, and that the device unable to be retrieved, although, no removal attempt has been made, pain, being sick and unable to walk or bear weight on right leg for a week, and anxiety.The patient reportedly became aware of these events approximately 3 years and 1-month post implantation.The indication for the filter implant was pulmonary embolism with a contraindication to anticoagulation.The filter was placed via the right groin and deployed at the infrarenal level.The patient reportedly tolerated the procedure well with no immediate complications.Approximately 2 years and 1- month post implantation, patient underwent a computed tomography (ct) scan.The impression from that scan noted that there was a filling defect in the medial right lower lobe pulmonary artery suggesting pulmonary embolus of uncertain age.Parenchymal calcification, small cavitary lesion in the superior segment of the right lower lobe of a wedge-shaped consolidation were noted.Right lower lobe hilar adenopathy mild thoracic aortic aneurysm, and mild right lower lobe bronchiectasis were also noted.There is currently no additional information available for review.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 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.Transient pain, unable to bear weight, ¿being sick¿ and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Given the limited information currently available for review, there is nothing to suggest that 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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