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| Model Number 466FXXXX |
| Device Problem
Failure to Align (2522)
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| Patient Problems
Calcium Deposits/Calcification (1758); Occlusion (1984); Perforation (2001); Thrombosis (2100); Thrombus (2101); Stenosis (2263)
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| Event Date 04/25/2019 |
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Event Type
Injury
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Manufacturer Narrative
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It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused tilt and perforation of the filter, stenosis and the resultant symptoms.The indication for the filter placement was not 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 optease 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 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.Ivc filter tilt has been associated with the anatomy of the vessel, 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 tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.Stenosis is an abnormal narrowing in a blood vessel, with the limited information provided a relationship between the filter and the event could not be determined.The location of the stenosis has not been provided.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 in the legal brief, a patient underwent placement of an optease 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 tilting and perforation of the filter, stenosis 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 and suffering, loss of enjoyment of life, distress and other damages.
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Manufacturer Narrative
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It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused tilt and perforation of the filter, stenosis and the resultant symptoms.The patient reported becoming aware of inferior vena cava (ivc) perforation and tilting of the filter approximately seven years post implant.The patient also reports having to be on coumadin therapy for life and as a result, subsequent development of psychological injuries.The indication for the filter placement and the procedural details have not been provided.Approximately two months post implant, patient underwent an abdominal computed tomography (ct) scan.A clinical history of deep vein thrombosis was noted.The ct findings reported an ivc filter in place with thrombus surrounding the left aspect of the ivc filter.The distal ivc, iliac veins and common femoral veins also appear expanded and heterogeneous consistent with additional extensive thrombus.Other findings include a calculus in the distal right ureter with mild right hydronephrosis; an additional bilateral non obstructing renal calculi; a mildly complex cyst of the lower pole of the right kidney measuring up to 7.2 cm with thin peripheral calcification, and an indeterminate 1.5 cm low-attenuation lesion in the mid to upper pole of the left kidney.This could represent a proteinaceous or hemorrhagic cyst but enhancing lesion is possible.Diverticulosis and right groin subcutaneous nodules, possibly representing lymphadenopathy or post procedure changes were also noted.Another, undated, ct scan was compared to previous ct scan that was performed approximately seventeen days post implant.The findings noted the ivc filter in place at the l2-l3 level with the superior aspect of the filter again noted to be positioned just below the level of the left renal vein and near the level of the right renal vein.There is anterior tilt of the superior tip of this filter which impresses on the anterior ivc wall and posterior angulation of the inferior tip which impresses upon and could extend into or through the posterior ivc wall.There is chronic occlusion of the ivc below this filter which is scarred down to small caliber with chronic calcific thrombus.The ivc filter struts may extend into and/or through the caval wall.There has been interval development of chronic appearing calcification of the intrarenal ivc inferior to the filter which is markedly scarred down with some probable chronic scarring of the proximal left common iliac vein as well, and associated collateral venous dilatation, bilateral gonadal veins and probable recanalized umbilical vein.Other findings included scattered colonic diverticulosis.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 optease 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 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.Blood clots, clotting and/or occlusive thrombosis or occlusion within the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Calcification in a vessel may consist of plaque, a buildup of fat, cholesterol, calcium, and other substances found in the blood or, particularly in the pelvis, what is a called a phlebolith, specific to the pelvis.Phleboliths start as a blood clot and harden over time with calcium and can form in many parts of the body.Ivc filter tilt has been associated with the anatomy of the vessel, 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 tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.Stenosis is an abnormal narrowing in a blood vessel, with the limited information provided a relationship between the filter and the event could not be determined.The location of the stenosis has not been provided.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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 in the legal brief, a patient underwent placement of an optease 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 tilting and perforation of the filter, stenosis 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 and suffering, loss of enjoyment of life, distress and other damages.Approximately two months after the filter was implanted, the patient underwent an abdominal computed tomography (ct) scan.A clinical history of deep vein thrombosis was noted.The ct findings reported an inferior vena cava (ivc) filter in place with thrombus surrounding the left aspect of the ivc filter.The distal ivc, iliac veins and common femoral veins also appear expanded and heterogeneous consistent with additional extensive thrombus.Other findings included a calculus in the distal right ureter with mild right hydronephrosis; also present, an additional bilateral non obstructing renal calculi; a mildly complex cyst of the lower pole of the right kidney measuring up to 7.2 cm with thin peripheral calcification, and an indeterminate 1.5 cm low-attenuation lesion in the mid to upper pole of the left kidney.This could represent a proteinaceous or hemorrhagic cyst but enhancing lesion is possible.Diverticulosis and right groin subcutaneous nodules, possibly representing lymphadenopathy or post procedure changes were also noted.Results from this ct scan were compared with another ct completed a month prior, which was indicated for checking the ivc filter placement and for an unspecified injury of the inferior vena cava.The ct scan findings noted chronic inferior vena cava filter remains with superior tip just below the level of the left renal vein and probably near the level of the right renal vein.There has been interval development of chronic appearing calcification of the intrarenal ivc inferior to the filter which is markedly scarred down with some probable chronic scarring of the proximal left common iliac vein as well, and associated collateral venous dilatation, bilateral gonadal veins and probable recanalized umbilical vein.Other findings included scattered colonic diverticulosis.This report was amended approximately six years and eight months later.The amended reported noted the ivc filter in place at the l2-l3 level with the superior aspect of the filter again noted to be positioned just below the level of the left renal vein and near the level of the right renal vein.Probably an optease ivc filter or similar model.There is anterior tilt of the superior tip of this filter which impresses on the anterior ivc wall and posterior angulation of the inferior tip which impresses upon and could extend into or through the posterior ivc wall.There is chronic occlusion of the ivc below this filter which is scarred down to small caliber with chronic calcific thrombus.The ivc filter struts may extend into and/or through the caval wall.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately seven years post implantation.The patient reports ivc perforation and tilting of the filter.The patient further asserts to having to be on coumadin therapy for life and as a result, subsequent development of psychological injuries.
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Manufacturer Narrative
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It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused tilt and perforation of the filter, stenosis and the resultant symptoms.The patient reported becoming aware of inferior vena cava (ivc) perforation and tilting of the filter approximately seven years post implant.The patient also reports having to be on coumadin therapy for life and as a result, subsequent development of psychological injuries.According to the implant records, the patient was reported to have ureteral stones, had been admitted to the hospital with hematuria, and was also found to have a right lower extremity deep vein thrombosis (dvt).The ivc filter placement was indicated as the patient was not a candidate for anticoagulation due to bleeding problems and required future surgeries for ureteric stones.The filter was placed via the right common femoral vein and deployed exactly below the renal veins, post deployment completion venogram revealed a widely patent vena cava.There was no extravasation.The filter was opposing the vein walls of the vena cava and there was no tilt.The patient tolerated the procedure and was sent to recovery room in a stable condition.Approximately two months post implant, the patient underwent an abdominal computed tomography (ct) scan.The ct findings reported an ivc filter in place with thrombus surrounding the left aspect of the ivc filter.The distal ivc, iliac veins and common femoral veins also appear expanded and heterogeneous consistent with additional extensive thrombus.Another, undated, ct scan was compared to the previous ct scan that was performed approximately seventeen days post implant.The findings noted the ivc filter in place at the l2-l3 level with the superior aspect of the filter again noted to be positioned just below the level of the left renal vein and near the level of the right renal vein.There is anterior tilt of the superior tip of this filter which impresses on the anterior ivc wall and posterior angulation of the inferior tip which impresses upon and could extend into or through the posterior ivc wall.There is chronic occlusion of the ivc below this filter which is scarred down to small caliber with chronic calcific thrombus.The ivc filter struts may extend into and/or through the caval wall.There has been interval development of chronic appearing calcification of the intrarenal ivc inferior to the filter which is markedly scarred down with some probable chronic scarring of the proximal left common iliac vein as well, and associated collateral venous dilatation, bilateral gonadal veins and probable recanalized umbilical vein.Other findings included scattered colonic diverticulosis.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 optease 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 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.Blood clots, clotting and/or occlusive thrombosis or occlusion within the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Calcification in a vessel may consist of plaque, a buildup of fat, cholesterol, calcium, and other substances found in the blood or, particularly in the pelvis, what is a called a phlebolith, specific to the pelvis.Phleboliths start as a blood clot and harden over time with calcium and can form in many parts of the body.Ivc filter tilt has been associated with the anatomy of the vessel, 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 tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.Stenosis is an abnormal narrowing in a blood vessel, with the limited information provided a relationship between the filter and the event could not be determined.The location of the stenosis has not been provided.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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 in the legal brief, a patient underwent placement of an optease 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 tilting and perforation of the filter, stenosis 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 and suffering, loss of enjoyment of life, distress and other damages.Approximately two months after the filter was implanted, the patient underwent an abdominal computed tomography (ct) scan.A clinical history of deep vein thrombosis was noted.The ct findings reported an inferior vena cava (ivc) filter in place with thrombus surrounding the left aspect of the ivc filter.The distal ivc, iliac veins and common femoral veins also appear expanded and heterogeneous consistent with additional extensive thrombus.Other findings included a calculus in the distal right ureter with mild right hydronephrosis; also present, an additional bilateral non obstructing renal calculi; a mildly complex cyst of the lower pole of the right kidney measuring up to 7.2 cm with thin peripheral calcification, and an indeterminate 1.5 cm low-attenuation lesion in the mid to upper pole of the left kidney.This could represent a proteinaceous or hemorrhagic cyst but enhancing lesion is possible.Diverticulosis and right groin subcutaneous nodules, possibly representing lymphadenopathy or post procedure changes were also noted.Results from this ct scan were compared with another ct completed a month prior, which was indicated for checking the ivc filter placement and for an unspecified injury of the inferior vena cava.The ct scan findings noted chronic inferior vena cava filter remains with superior tip just below the level of the left renal vein and probably near the level of the right renal vein.There has been interval development of chronic appearing calcification of the intrarenal ivc inferior to the filter which is markedly scarred down with some probable chronic scarring of the proximal left common iliac vein as well, and associated collateral venous dilatation, bilateral gonadal veins and probable recanalized umbilical vein.Other findings included scattered colonic diverticulosis.This report was amended approximately six years and eight months later.The amended reported noted the ivc filter in place at the l2-l3 level with the superior aspect of the filter again noted to be positioned just below the level of the left renal vein and near the level of the right renal vein.Probably an optease ivc filter or similar model.There is anterior tilt of the superior tip of this filter which impresses on the anterior ivc wall and posterior angulation of the inferior tip which impresses upon and could extend into or through the posterior ivc wall.There is chronic occlusion of the ivc below this filter which is scarred down to small caliber with chronic calcific thrombus.The ivc filter struts may extend into and/or through the caval wall.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately seven years post implantation.The patient reports ivc perforation and tilting of the filter.The patient further asserts to having to be on coumadin therapy for life and as a result, subsequent development of psychological injuries.Per the implant records, the patient was reported to have ureteral stones, had been admitted to the hospital with hematuria, and was also found to have a right lower extremity deep vein thrombosis (dvt).The ivc filter placement was indicated as the patient was not a candidate for anticoagulation due to bleeding problems and required future surgeries for ureteric stones.The right groin area was infiltrated, and the right common femoral vein was punctured.Under fluoroscopic control, an inferior vena cavogram was obtained, which revealed a widely patent iliac vein and inferior vena cava with no filling defects.The renal veins were at the level of l1.The optease inferior vena cava filter was deployed exactly below the renal veins and post deployment completion venogram revealed a widely patent vena cava.There was no extravasation.The filter was opposing the vein walls of the vena cava and there was no tilt.The patient tolerated the procedure and was sent to recovery room in a stable condition.
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