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| Catalog Number 466P306X |
| Device Problems
Fracture (1260); Occlusion Within Device (1423); Unintended Movement (3026)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984); Internal Organ Perforation (1987); Swelling (2091); Perforation of Vessels (2135); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 03/07/2015 |
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Event Type
Injury
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Manufacturer Narrative
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As reported, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting, occlusion of the inferior vena cava (ivc) filter and inability to be retrieved.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 received per the medical records indicate that the patient has a history of lumbar degenerative disease, dyspnea on exertion, edema, microscopic hematuria, occult blood in stools, osteoporosis, chronic cystitis, chronic kidney disease, klinefelter¿s syndrome, iron deficiency anemia, vitamin b12 deficiency, hematuria, hypertriglyceridemia, impaired fasting glucose, mixed hyperlipidemia, hypogonadism, coronary artery disease (cad).The patient had the filter placed due to a pulmonary embolism (pe).Nine years and five months post implantation the patient received a computerized tomography (ct) scan which showed occlusion of the ivc filter with collaterals.The patient stated in the medical records to be suffering from lower bilateral extremity swelling, most specifically in the ankles.According to the information received in the patient profile from (ppf), the patient became aware of the reported events two years and eleven months post implantation.Although the brief reports that the device is unable to be retrieved, there have been no attempts made to remove the filter.The patient also reports to be suffering from anxiety and shortness of breath.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.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.Thrombosis of the ivc, iliac veins, recurrent dvt¿s and occlusion of the ivc filter do not represent a device malfunction.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency and leg swelling.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.The brief mentioned collateral circulation.Collateral circulation is the circulation of blood established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.After review of the limited medical records received, a clinical conclusion for the shortness of breath experienced by the patient, per the ppf, could not be determined.The profile form received also stated that the device was unable to be retrieved although no known attempt has been made.The cordis trapease vena cava filter is designed as a permanent vena cava filter.Six straight struts that contain a proximal and distal hooks are designed for fixation of the trapease filter to the vessel wall.Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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 trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting, occlusion of the inferior vena cava (ivc) filter and inability to be retrieved.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 received per the medical records indicate that the patient has a history of lumbar degenerative disease, dyspnea on exertion, edema, microscopic hematuria, occult blood in stools, osteoporosis, chronic cystitis, chronic kidney disease, klinefelter¿s syndrome, iron deficiency anemia, vitamin b12 deficiency, hematuria, hypertriglyceridemia, impaired fasting glucose, mixed hyperlipidemia, hypogonadism, coronary artery disease (cad).The patient had the filter placed due to a pulmonary embolism (pe).Nine years and five months post implantation the patient received a computerized tomography (ct) scan which showed occlusion of the ivc filter with collaterals.The patient stated in the medical records to be suffering from lower bilateral extremity swelling, most specifically in the ankles.According to the information received in the patient profile from (ppf), the patient became aware of the reported events two years and eleven months post implantation.Although the brief reports that the device is unable to be retrieved, there have been no attempts made to remove the filter.The patient also reports to be suffering from anxiety and shortness of breath.
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Manufacturer Narrative
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Additional information received per the discovery form (df) indicate that the patient had a history of blood clot in lungs.The form also states that the patient experienced a staph infection.As reported, the patient had placement of trapease inferior vena cava (ivc) filter.Per the medical records, history includes pulmonary emboli, lumbar degenerative dis disease, dyspnea on exertion, edema, microscopic hematuria, occult blood in stools, osteoporosis, chronic cystitis, chronic kidney disease, klinefelter¿s syndrome, iron deficiency anemia, vitamin b12 deficiency, hematuria, hypertriglyceridemia, impaired fasting glucose, mixed hyperlipidemia, hypogonadism, coronary artery disease (cad).The filter was placed due to a pulmonary embolism (pe).The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting, occlusion of the inferior vena cava (ivc) filter and inability to be retrieved.Nine years and five months post implant, a ct scan, done for gross hematuria, revealed occlusion of the ivc filter with marked abdominal and pelvic venous collaterals despite anticoagulation.Per the patient profile from (ppf), the patient reports blood clots, clotting and/or occlusion of the ivc, lower bilateral extremity swelling, most specifically in the ankles.Although it is reported that the device is unable to be retrieved, there have been no attempts made to remove the filter.The patient also reports anxiety and shortness of breath.Approximately eleven years and five months post implant, the patient had treatment of poison ivy.Two weeks later the patient underwent cystoscopy with bladder biopsies and fulguration for bladder wall erythema.No definitive masses were located.The study did reveal multiple erythematous linear lesions.Biopsies were obtained and the areas cauterized.Biopsy were not provided.Two weeks after that, the patient presented to a physician results with filter occlusion.The patient reported having chronic swelling of the bilateral lower extremities.The patient further reported firmness and tenderness around the ankles that he believed were superficial clots.The patient further reports a staph infection post implant.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 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, swelling, shortness of breath, collateral circulation and nos movement disorder 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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Manufacturer Narrative
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Additional information received per the medical records indicate that the patient underwent a computed tomography (ct) scans approximately nine years and five months after the index procedure for evaluation of gross hematuria.The study revealed no evidence of urinary tract calculus or hydronephrosis; but did note an incidental finding of occlusion of the filter with marked abdominal and pelvic venous collaterals despite anticoagulation.Approximately eleven years and five months after the index procedure, the patient presented to an urgent care facility for treatment of poison ivy.Two weeks later the patient underwent cystoscopy with bladder biopsies and fulguration for bladder wall erythema.No definitive masses were located.The study did reveal multiple erythematous linear lesions.Biopsies were obtained and the areas cauterized.Biopsy results were not provided.Two weeks after that, the patient presented to a physician with filter occlusion.The patient reported having chronic swelling of the bilateral lower extremities.The patient further reported firmness and tenderness around the ankles that he believed were superficial clots.Additional information received per the patient profile form (ppf) states that the patient experienced anxiety, blood clots, clotting and/or occlusion of the ivc.The patient became aware of the reported events nine years and five months after the index procedure.The form also states that the patient cannot bend over.As reported, the patient had placement of trapease inferior vena cava (ivc) filter.Per the medical records, history includes lumbar degenerative disc disease, dyspnea on exertion, edema, microscopic hematuria, occult blood in stools, osteoporosis, chronic cystitis, chronic kidney disease, klinefelter¿s syndrome, iron deficiency anemia, vitamin b12 deficiency, hematuria, hypertriglyceridemia, impaired fasting glucose, mixed hyperlipidemia, hypogonadism, coronary artery disease (cad).The indication for the filer was pulmonary embolism (pe).The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting, occlusion of the inferior vena cava (ivc) filter and inability to be retrieved.A ct scan, nine years and five months post implantation, done for hematuria, revealed no evidence of urinary tract calculus or hydronephrosis; but did note an incidental finding of occlusion of the filter with marked abdominal and pelvic venous collaterals despite anticoagulation.Per the medical records, the patient reports lower bilateral extremity swelling, most specifically in the ankles.Per the patient profile from (ppf), the patient reports device is unable to be retrieved; however, there have been no attempts made to remove the filter.The patient also reports to be suffering from anxiety and shortness of breath.Approximately eleven years and five months after the index procedure, the patient presented to an urgent care facility for treatment of poison ivy.Two weeks later the patient underwent cystoscopy with bladder biopsies and fulguration for bladder wall erythema.No definitive masses were located.The study did reveal multiple erythematous linear lesions.Biopsies were obtained and the areas cauterized.Biopsy results were not provided.Two weeks after that, the patient presented to a physician with filter occlusion.The patient reported having chronic swelling of the bilateral lower extremities.The patient further reported firmness and tenderness around the ankles that he believed were superficial clots.Per the patient profile form (ppf), the patient experienced anxiety, blood clots, clotting and/or occlusion of the ivc.The form also states that the patient cannot bend over.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 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Blood clots and occlusive thrombosis within the filter and vasculature, with resultant swelling, do not represent a device malfunction.Anxiety and shortness of breath 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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Computed tomography (ct) scans done approximately fourteen years and four months after the index procedure were evaluated approximately fifteen years and four months after the index procedure.The superior end of the trapease filter was at the l2-l3 interspace.The inferior vena cava (ivc) filter was not tilted at the superior end.The ivc filter was tilted anteriorly at the inferior end and it contacted the ivc wall.All the struts of the ivc filter perforate the ivc up to 9mm.Two (2) anterior struts perforate the ivc wall (both at 4mm) and reside within the soft tissues.One (1) medial strut perforates the ivc wall 9mm and contacts the aorta.Two (2) posterior struts perforate the ivc wall both 6mm and contact the l4 vertebral body.One (1) lateral strut perforates the ivc wall 7mm and resides within the soft tissues.There was a calcific density within the lumen of the ivc filter at the superior and inferior ends.This may be related to chronic calcified clot formation.There was one (1) lateral strut fracture and one (1) medial strut fracture.No hemorrhage was seen.No thrombus was seen within the ivc.Additional information was received per a third amended patient profile form (ppf).The form states that in addition to previously reported events, the patient also experienced filter fracture, perforation of filter struts outside the ivc, perforation of organs and calcified density within the lumen of the ivc at the inferior and inferior ends.It states that these may be related to chronic calcified clot formation.The patient became aware of the reported events approximately fifteen years and four months after the index procedure.
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Manufacturer Narrative
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Section h6: health effect - clinical code: code 4581was used for 'calcified clot'.As reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.Per the medical records, history includes lumbar degenerative disc disease, dyspnea on exertion, edema, microscopic hematuria, occult blood in stools, osteoporosis, chronic cystitis, chronic kidney disease, klinefelter¿s syndrome, iron deficiency anemia, vitamin b12 deficiency, hematuria, hypertriglyceridemia, impaired fasting glucose, mixed hyperlipidemia, hypogonadism, coronary artery disease (cad) and pulmonary embolism.The indication for filter was pulmonary embolism (pe).The filter subsequently malfunctioned including blood clots, clotting, occlusion of the ivc filter and inability to be retrieved.No retrieval attempts are reported.Nine years and five months post implant, a ct scan done for hematuria revealed occlusion of the ivc filter with collateral vein formation associated to legs swelling.Approximately eleven years and five months post implant, the patient was treated for poison ivy rash.Two weeks later, cystoscopy revealed multiple erythematous linear lesions treated with cauterization.Nine years and six months post implant, the patient reported chronic swelling of both legs, and was diagnosed with ivc filter occlusion and possible superficial venous clots around ankles.Per the patient profile form (ppf), the patient reports filter fracture, perforation of filter struts outside the ivc, perforation of organs and calcified clot in the filer, anxiety, blood clots, clotting and/or occlusion of the ivc and an inability to bend over.The patient also reports a staphylococcus infection.Approximately 14 years and 4 months post implant, a ct scan was done and re-evaluated at 15 years and 4 months post implant.The scan revealed the filter at the l2-3 interspace, tilt is noted at the inferior end, in contact with the ivc wall.All struts perforate the ivc up to 9mm.Two (2) anterior struts perforate the ivc wall (both at 4mm) and reside within the soft tissues.One (1) medial strut perforates the ivc wall 9mm and contacts the aorta.Two (2) posterior struts perforate the ivc wall both 6mm and contact the l4 vertebral body.One (1) lateral strut perforates the ivc wall 7mm and resides within the soft tissues.There was a calcific density, maybe related to chronic calcified clot, within the lumen of the ivc filter at the superior and inferior ends.There was one (1) lateral strut fracture and one (1) medial strut fracture.No hemorrhage was seen.No thrombus was seen within the ivc.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 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.The instructions for use (ifu) states filter fracture with perforation is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.It was reported that there was perforation of the ivc and organs; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Blood clots, occlusive thrombosis and calcified clot within the filter and vasculature do not represent a device malfunction.Anxiety, swelling, inability to bend over, shortness of breath and collateral circulation 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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Manufacturer Narrative
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As reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.Per the medical records, history includes lumbar degenerative disc disease, dyspnea on exertion, edema, microscopic hematuria, occult blood in stools, osteoporosis, chronic cystitis, chronic kidney disease, klinefelter¿s syndrome, iron deficiency anemia, vitamin b12 deficiency, hematuria, hypertriglyceridemia, impaired fasting glucose, mixed hyperlipidemia, hypogonadism, coronary artery disease (cad) and pulmonary embolism.The indication for filter was pulmonary embolism (pe).The filter subsequently malfunctioned including blood clots, clotting, occlusion of the ivc filter and inability to be retrieved.No retrieval attempts are reported.Nine years and five months post implant, a ct scan done for hematuria revealed occlusion of the ivc filter with collateral vein formation associated to legs swelling.Approximately eleven years and five months post implant, the patient was treated for poison ivy rash.Two weeks later, cystoscopy revealed multiple erythematous linear lesions treated with cauterization.Nine years and six months post implant, the patient reported chronic swelling of both legs, and was diagnosed with ivc filter occlusion and possible superficial venous clots around ankles.Per the patient profile form (ppf), the patient reports filter fracture, perforation of filter struts outside the ivc, perforation of organs and calcified clot in the filer, anxiety, blood clots, clotting and/or occlusion of the ivc and an inability to bend over.The patient also reports a staphylococcus infection.Approximately 14 years and 4 months post implant, a ct scan was done and re-evaluated at 15 years and 4 months post implant.The scan revealed the filter at the l2-3 interspace, tilt is noted at the inferior end, in contact with the ivc wall.All struts perforate the ivc up to 9mm.Two (2) anterior struts perforate the ivc wall (both at 4mm) and reside within the soft tissues.One (1) medial strut perforates the ivc wall 9mm and contacts the aorta.Two (2) posterior struts perforate the ivc wall both 6mm and contact the l4 vertebral body.One (1) lateral strut perforates the ivc wall 7mm and resides within the soft tissues.There was a calcific density, maybe related to chronic calcified clot, within the lumen of the ivc filter at the superior and inferior ends.There was one (1) lateral strut fracture and one (1) medial strut fracture.No hemorrhage was seen.No thrombus was seen within the ivc.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 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.The instructions for use (ifu) states filter fracture with perforation is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.It was reported that there was perforation of the ivc and organs; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Blood clots, occlusive thrombosis and calcified clot within the filter and vasculature do not represent a device malfunction.Anxiety, swelling, inability to bend over, shortness of breath and collateral circulation do not represent a device malfunction and may be related to underlying patient related issues.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.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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Search Alerts/Recalls
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