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Catalog Number 466P306X |
Device Problem
Unintended Movement (3026)
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Patient Problems
Internal Organ Perforation (1987); Stenosis (2263)
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Event Date 10/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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 filter is tilted (touches the inferior vena cava (ivc) wall), demonstrates diffuse stenosis and 3mm mesenteric perforation.The indication for the filter implant 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.Stenosis is an abnormal narrowing of a vessel; this does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported perforation, tilt and stenosis could not be confirmed or further clarified.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.Please note that this is the initial report for this product.
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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 report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to the filter is tilted (touches the inferior vena cava (ivc) wall), demonstrates diffuse stenosis and 3mm mesenteric perforation.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, pain and suffering, and other damages.
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Manufacturer Narrative
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After further review of additional information received, the following sections have been updated accordingly: additional information is pending and will be submitted within 30 days of receipt.
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Event Description
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Additional information received per the patient profile form (ppf) states that the patient experienced filter tilt, perforation of filter strut(s) into organs and mesentery.The patient reported that their mental health declined due to a lack of mobility from being clogged, swelling in legs and in feet due to poor circulation (blood unable to get back to heart properly).Approximately nine years and three months after the index procedure an abdominal computed tomography (ct) scan was done to evaluate the filter.The images revealed: a 3mm mesenteric perforation, tilting with the apex against the ivc wall, and ivc stenosis.There were no fractures or migration.
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Manufacturer Narrative
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After further review of additional information received, the following sections have been updated accordingly: b4, b5, b7, d10, g3, g6, h1 and h2.Additional information is pending and will be submitted within 30 days of receipt.
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Event Description
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Additional information received per the medical records indicate that the patient has a history of pulmonary embolism (pe), right lower extremity deep vein thrombosis (dvt), recent fall, coronary artery disease (stable), chronic obstructive pulmonary disease (copd) (stable), degenerative joint disease, tobacco abuse, hemarthrosis of the left elbow secondary to heparin and leukocytosis of questionable etiology.The filter was implanted via the patient's right femoral vein.Using fluoroscopic guidance, the filter was deployed at a level just above the inferior margin of l2.The filter appeared to be well seated.Post placement venogram demonstrated the filter to be in a good position.The patient tolerated the procedure well and there were no immediate complications.
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Manufacturer Narrative
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After further review of additional information received, the following sections have been updated accordingly: b4, g3, g6, h1, h2 and h6.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 filter is tilted (touches the inferior vena cava (ivc) wall), demonstrates diffuse stenosis and 3mm mesenteric perforation.The patient reported becoming aware of the events approximately nine years and eight months post implant.The patient also reported a decline in mental health due to a lack of mobility from being clogged, swelling in legs and in feet due to poor circulation (blood unable to get back to heart properly).Approximately nine years and three months post implant an abdominal computed tomography (ct) scan was done to evaluate the filter.The results noted a 3mm mesenteric perforation, tilting with the apex against the ivc wall, and ivc stenosis.There were no fractures or migration.Additional information received per the medical records indicate that the patient had a history of pulmonary embolism (pe), right lower extremity deep vein thrombosis (dvt), recent fall, coronary artery disease (stable), chronic obstructive pulmonary disease, degenerative joint disease, tobacco abuse, hemarthrosis of the left elbow secondary to heparin and leukocytosis of questionable etiology.The indication for the filter implant was pe.The filter was implanted via the right femoral vein and was deployed at a level just above the inferior margin of l2, under fluoroscopic guidance.The filter appeared to be well seated.Post placement venogram demonstrated the filter to be in a good position.The patient tolerated the procedure well and there were no immediate complications.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.Stenosis is an abnormal narrowing of a vessel; this does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.Stenosis of the ivc can interfere with the returning circulation to the heart and result in poor circulation problems and swelling of the lower extremities.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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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