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| Model Number 466P306AU |
| Device Problems
Retraction Problem (1536); Obstruction of Flow (2423)
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| Patient Problems
Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Stenosis (2263); Thrombosis/Thrombus (4440)
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| Event Date 11/27/2014 |
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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, recurrent dvts of rle and lle, complete occlusion of the ivc filter, and the ivc filter is crushed and cannot be removed.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 product was not returned for analysis.Additionally, as the sterile lot number was not available, a device history record review could not be performed.The trapease 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.Dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf), and can spread up to the veins in the thigh.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Factors that may have influenced the event include patient, pharmacological and lesion.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.The cordis trapease® permanent 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.Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling, including being crushed.The off label use of this filter likely contributed to the retrieval difficulty experienced by the customer.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/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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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, recurrent dvts of rle and lle, complete occlusion of the ivc filter, and the ivc filter is crushed and cannot be removed.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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As reported, the patient had placement of the trapease inferior vena cava (ivc) filter.The indication for an ivc filter was factor v leiden, deep vein thrombosis (dvt), hypercoagulability, and peripheral vascular disease.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent dvts of rle and lle, complete occlusion of the ivc filter, and the filter is crushed and cannot be removed.Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc.The patient also reports suffering from anxiety, pain, blood clots in legs, and problems with mobility.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.Altered shape of the device is a known potential event associated with use of the ivc filters, the ivc is a dynamic vessel subject to ongoing physical stressed and this and impact the shape of the filter struts over time.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, decreased mobility 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 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, recurrent dvts of rle and lle, complete occlusion of the ivc filter, and the ivc filter is crushed and cannot be removed.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.According to the information received in the patient profile form (ppf), patient reports blood clots, clotting, and/or occlusion of the ivc.The patient also reports suffering from pain, blood clots in legs, and problems with mobility.According to the discovery form, the patient received the ivc filter due to factor v leiden, deep vein thrombosis (dvt), hypercoagulability, and peripheral vascular disease.Medical conditions and treatments alleged to be attributable to the implanted ivc filter include hypercoagulability and peripheral vascular disease.Furthermore, it was reported that the filter could not be removed; "it had to be crushed" and remains in the vena cava, although ivc filter removal attempt information and details have not been provided.The patient also reports constant pain and clotting in the legs and back, and constant fear and worrying that pieces of the filter or clots could break off and cause death.The patient further reports leg disability and inability to walk at times in addition to ultrasounds and medical procedures twice a year to determine filter placement and to check for any new developments of clots.
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Manufacturer Narrative
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Complaint conclusion: as reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent dvts of rle and lle, complete occlusion of the ivc filter, and the ivc filter is crushed and cannot be removed.Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc.The patient also reports suffering from pain, blood clots in legs, and problems with mobility.The filter remains implanted; thus, unavailable for analysis.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.Altered shape of the device is a known potential event associated with use of the ivc filters, the ivc is a dynamic vessel subject to ongoing physical stressed and this and impact the shape of the filter struts over time.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Decreased mobility 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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Manufacturer Narrative
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Correction to (product code).
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Manufacturer Narrative
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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, recurrent dvts of rle and lle, complete occlusion of the ivc filter, and the ivc filter is crushed and cannot be removed.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.According to the information received in the patient profile form (ppf), patient reports blood clots, clotting, and/or occlusion of the ivc.The patient also reports suffering from pain, blood clots in legs, and problems with mobility.
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Event Description
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The medical records provided for review revealed a clinical history of arthritis, right leg dvt (five years prior), chronic right leg pain, factor v leiden mutation, gastroesophageal reflux disease (gerd), hyperlipidemia, hypertension, peripheral vascular disease, parkinson¿s, gastric ulcers, depression, anxiety, and chronic low back pain.Per the implant records, the patient was reported to have a preoperative diagnosis of right femoropopliteal deep venous thrombosis (dvt) and pain in the limb.Both groins were prepared in sterile fashion.The common femoral vein was cannulated with a micro venous needle and a guidewire was introduced, followed by placement of a micro venous sheath.A venacavagram was then performed demonstrating patency of the left leg vein and a widely patent vena cava.This was followed by placement of a regular guidewire, and a sheath was used to dilate the left femoral vein.The delivery sheath along with the inferior vena cava (ivc) filter was taken successfully without complications to the level above l2.Following filter placement, a venogram of the left lower extremity, demonstrated flow through the tibial, femoral, popliteal, and iliac vein systems on the left side and patency.Additionally, the right tibial vein was patent; dvt was noted in the femoropopliteal segment.Tissue plasminogen activator (tpa) thrombolysis and thrombectomy with angiojet was also performed during the filter implant.The report noted that since the filter had already been placed, the patient might require angiojet embolectomy for further improvement of the dvt.Approximately two years after the filter was implanted, findings of a magnetic resonance imaging (mri) of the lumbar spine indicated for low back pain reported central disc protrusion at l5-s1, disc bulging at l4-l5 with mild central canal stenosis and neural foramina stenosis.The following day, the patient underwent a right lower extremity ascending venogram and tissue plasminogen activator (tpa) infusion procedure due to worsening leg pain and swelling despite compression stockings.Results of the venogram noted dvt of the right leg in the distal femoral and popliteal vein, noted to be acute on chronic.A repeat venogram performed the following day showed improvement in the right lower leg.The recommendation was to continue the tpa for another 24 hours.Approximately one-month later, the patient was admitted due to acutely worsening leg pain and swelling.An ultrasound of the left leg showed dvt of the lle the patient underwent lle and ivc venogram with tpa and angiojet, left iliac vein, common femoral vein and infrarenal ivc angioplasty, left femoral vein angioplasty and lle venogram from the foot and popliteal vein.Findings noted thrombosis of the infrarenal ivc, partial thrombosis of the ivc filter, dvt of the left iliac, common femoral and posterior tibial vein and eighty-per-cent stenosis of the left external iliac vein.Four days later lle venogram with left common iliac vein and ivc angiojet and angioplasty was repeated.Findings noted thrombosis of the left common iliac vein and ivc below the filter, improvement in flow and symptoms of the previously occluded left common femoral vein, the external leg vein opened with a raised stenosis, chronic appearing thrombus of the ivc and left common iliac vein (ninety per-cent).A day later, the patient underwent left lower extremity venogram, left femoral vein, common femoral vein, iliac and ivc angiojet with tpa and aspiration and angioplasty due to a clotted left iliac and ivc stent, and femoral thrombosis (lle dvt with phlegmasia).Findings noted clotted left iliac and ivc stent, femoral vein thrombosis.It was noted at the end of the procedure that the leg was soft with improving symptoms; however, it was felt that once the tpa was stopped the stents would clot off again.Anticoagulation outside the institution was recommended, and suction thrombectomy of the bilateral iliac veins with balloon angioplasty bilaterally and of the ivc in addition to lysis of the bilateral lower extremities and re-stenting of the distal left external iliac vein and common femoral vein was also completed in the two days that followed with stenting of the ivc and bilateral iliac veins.About two years and three months post implant, a duplex ultrasound of the ivc and bilateral iliac veins found no evidence of acute dvt.A follow up on stenting of the ivc and bilateral iliac veins was completed two months later.Results showed acute dvt of the ivc and no acute dvt of the bilateral iliac veins.Due to these findings, the patient underwent stenting of the ivc with balloon angioplasty.About three years and six months after the filter was implanted, the patient underwent bilateral iliac venogram and had an intravascular ultrasound (ivus) with balloon angioplasty of the left external iliac vein for complaints of bilateral lower extremity swelling.Approximately four years and two months post implant, bilateral venograms of iliac veins and ivc, were indicated also for bilateral lower extremity swelling.Findings noted patent femoral iliac veins and ivc with no evidence of flow limiting lesion or dissection with patent stents in both the left common femoral, ivc and right iliac stents.No evidence of thrombus or stenosis throughout the previously placed ivc and iliac stents.Results of a bilateral duplex ultrasound repeated about two months later noted chronic dvt in the right popliteal vein and no evidence of dvt in the left lower extremity.
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Manufacturer Narrative
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As reported a patient underwent placement of the trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused recurrent chronic deep vein thrombosis (dvt)s of right lower extremity (rle) and left lower extremity (lle), complete occlusion of the ivc filter, and the ivc filter is crushed and cannot be removed.The patient reported blood clots, clotting, and/or occlusion of the ivc, pain, blood clots in legs, and problems with mobility.The medical records provided for review revealed a clinical history of arthritis, right leg dvt (five years prior), chronic right leg pain, factor v leiden mutation, gastroesophageal reflux disease (gerd), hyperlipidemia, hypertension, peripheral vascular disease, parkinson¿s, gastric ulcers, depression, anxiety, and chronic low back pain.According to the procedure record the indication for the filter placement was deep vein thrombosis of the right femoropopliteal vein and pain in the limb.The filter was placed via the left femoral vein and deployed to the level above l2 without complications.Following filter placement, a venogram of the lle, demonstrated flow through the tibial, femoral, popliteal, and iliac vein systems on the left side and patency.Additionally, the right tibial vein was patent; dvt was noted in the femoropopliteal segment.Tissue plasminogen activator (tpa) thrombolysis and thrombectomy with angiojet was also performed during the filter implant.The following day, the patient underwent a right lower extremity ascending venogram and tpa infusion procedure due to worsening leg pain and swelling despite compression stockings.Results of the venogram noted dvt of the right leg in the distal femoral and popliteal vein, noted to be acute on chronic.A repeat venogram performed the following day showed improvement in the right lower leg.The recommendation was to continue the tpa for another 24 hours.Approximately one-month later, the patient was admitted due to acutely worsening leg pain and swelling.An ultrasound of the left leg showed dvt of the left lower extremity (lle).The patient underwent lle and ivc venogram with tpa and angiojet, left iliac, common femoral and infrarenal ivc angioplasty, left femoral angioplasty and lle venogram from the foot and popliteal vein.Findings noted thrombosis of the infrarenal ivc, partial thrombosis of the ivc filter, dvt of the left iliac, common femoral and posterior tibial vein and eighty-per-cent stenosis of the left external iliac vein.Four days later lle venogram with left common iliac vein and ivc angiojet and angioplasty was repeated.Findings noted thrombosis of the left common iliac vein and ivc below the filter, improvement in flow and symptoms of the previously occluded left common femoral vein, the external leg vein opened with a raised stenosis, chronic appearing thrombus of the ivc and left common iliac vein (ninety per-cent).A day later, the patient underwent left lower extremity venogram of the left femoral, common femoral, iliac and ivc veins.Angiojet with tpa and aspiration and angioplasty due to a clotted left iliac and ivc stent, and femoral thrombosis (lle dvt with phlegmasia).It was noted at the end of the procedure that the leg was soft with improving symptoms; however, it was felt that once the tpa was stopped the stents would clot off again.Anticoagulation outside the institution was recommended, and suction thrombectomy of the bilateral iliac veins with balloon angioplasty bilaterally and of the ivc in addition to lysis of the bilateral lower extremities and re-stenting of the distal left external iliac and common femoral veins was also completed in the two days that followed with stenting of the ivc and bilateral iliac veins.Approximately four months later a follow up on stenting of the ivc and bilateral iliac veins was completed.Results showed acute dvt of the ivc and no acute dvt of the bilateral iliac veins.Due to these findings, the patient underwent stenting of the ivc with balloon angioplasty.About three years and six months post implant, the patient underwent bilateral iliac venogram and had an intravascular ultrasound (ivus) with balloon angioplasty of the left external iliac vein for complaints of bilateral lower extremity swelling.Approximately four years and two months post implant, bilateral venograms of iliac veins and ivc, were indicated also for bilateral lower extremity swelling.Findings noted patent femoral iliac veins and ivc with no evidence of flow limiting lesion or dissection with patent stents in both the left common femoral, ivc and right iliac stents.No evidence of thrombus or stenosis throughout the previously placed ivc and iliac stents.Results of a bilateral duplex ultrasound repeated about two months later noted chronic dvt in the right popliteal vein and no evidence of dvt in the lle.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 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.Altered shape in patient was initially captured to reflect the device is crushed and cannot be removed, this event does not reflect a device malfunction and is related to occlusive thrombus developing in the ivc and filter and the use of stents and balloon angioplasty to achieve patency of the vessel.Blood clots, clotting, stenosis and occlusive thrombosis within the filter, ivc and approximate vasculature do not represent a device malfunction.Decreased mobility and pain also do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced these events include patient, pharmacological and vessel characteristics.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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