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Model Number 466P306X |
Device Problem
Defective Device (2588)
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Patient Problems
Internal Organ Perforation (1987); Perforation of Vessels (2135)
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Event Date 03/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, perforation of all struts outside the wall of the ivc with multiple struts perforating into surrounding tissue/organs.The exact implant date is unknown.The filter remains implanted; thus, unavailable for analysis.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.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.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.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 in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, perforation of all struts outside the wall of the inferior vena cava (ivc) with multiple struts perforating into surrounding tissue/organs.The exact implant date is unknown.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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As reported, the patient underwent placement of a trapease vena cava filter.At some point after the filter implantation, the patient became aware that filter struts had perforated outside the wall of the inferior vena cava (ivc) with multiple struts perforating into surrounding tissue and/or organs.The patient underwent a computerized tomography (ct) scan that revealed that the superior aspect of the filter was at the l1-l2.All of the filter struts had perforated the ivc by up to 4mm.One of the anterior struts is in contact with the right renal artery.Two of the lateral struts, one medial and one posterior strut were residing within the soft tissues.There was no evidence of filter tilt or fracture.The patient further reported having experienced numbness and swelling of both legs and feet, numbness of the hands and mental anguish associated with the filter.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 ivc 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.Without images or procedural films for review, the reported ivc and organ perforation events could not be confirmed and the exact cause could not be determined.It is unknown if the tilt contributed to the reported perforations.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Due to the nature of the complaint, the reported numbness and swelling experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information 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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Event Description
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As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, perforation of all struts outside the wall of the inferior vena cava (ivc) with multiple struts perforating into surrounding tissue/organs.The exact implant date is unknown.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.Per the medical records, the patient underwent a lumbar computerized tomography (ct) scan, which reported the superior end of the cordis trapease permanent inferior vena cava (ivc) filter at the l1-2 interspace.The ivc filter is not tilted.All the struts of the filter perforate the ivc up to 3mm.One anterior strut, one medial strut and a posterior strut perforate the ivc wall 3mm and reside within the soft tissues.A lateral strut perforates the ivc wall 2mm and also resides within the soft tissues.No fracture fragments were identified.The ct scan findings were compared with another lumbar ct completed three years earlier.The report noted that the original function of this ivc filter is permanent; therefore, it cannot be removed by a percutaneous approach.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the inferior vena cava, perforation of filter struts into organs, numbness and swelling in both legs and feet, partial numbness in both hands and further experienced anxiety related to the filter.The implant date is unknown.
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Manufacturer Narrative
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It was reported that a patient underwent placement of a trapease vena cava filter.At some point in time post implant, the patient became aware that filter struts had perforated outside the wall of the inferior vena cava (ivc) with multiple struts perforating into surrounding tissue and/or organs.Additional information received in the form of implant records, indicated that, prior to the implant, the patient had a lobectomy and post operatively developed deep vein thrombosis (dvt).The patient was on aspirin and plavix for a recent coronary stent placement and was started on coumadin.The patient presented with gastrointestinal (gi) bleeding and was referred for ivc filter placement for contraindication to anticoagulation.The filter was placed via the right femoral vein and deployed at the level of l2.Pre-deployment angiography identified the merger of the iliac veins at the level of l3 and the merger of the renal veins at the level of t12 -l1.The inferior vena cava was of normal caliber without evidence of thrombus.Repeat angiography showed good device opposition.At some point post implant, the patient underwent a computerized tomography (ct) scan.Results noted that the superior aspect of the filter was at the l1-l2.All of the filter struts had perforated the ivc by up to 4mm.One of the anterior struts is in contact with the right renal artery.Two of the lateral struts, one medial and one posterior strut were residing within the soft tissues.There was no evidence of filter tilt or fracture.The patient also reported numbness and swelling of both legs and feet, numbness of the hands and mental anguish associated with the filter.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 vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc 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.Without images or procedural films for review, the reported ivc and organ perforation events could not be confirmed nor an exact cause determined.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall with all filters imaged after 71 days from implant revealing some level of perforation.Due to the nature of the complaint, the reported numbness and swelling experienced by the patient could not be confirmed or further clarified.These clinical events and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information 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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Event Description
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As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, perforation of all struts outside the wall of the inferior vena cava (ivc) with multiple struts perforating into surrounding tissue/organs.The exact implant date is unknown.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.Per the medical records, the patient underwent a lumbar computerized tomography (ct) scan, which reported the superior end of the cordis trapease permanent inferior vena cava (ivc) filter at the l1-2 interspace.The ivc filter is not tilted.All the struts of the filter perforate the ivc up to 3mm.One anterior strut, one medial strut and a posterior strut perforate the ivc wall 3mm and reside within the soft tissues.A lateral strut perforates the ivc wall 2mm and also resides within the soft tissues.No fracture fragments were identified.The ct scan findings were compared with another lumbar ct completed three years earlier.The report noted that the original function of this ivc filter is permanent; therefore, it cannot be removed by a percutaneous approach.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the inferior vena cava, perforation of filter struts into organs, numbness and swelling in both legs and feet, partial numbness in both hands and further experienced anxiety related to the filter.Per the implant records, prior to the index procedure, the patient had a lobectomy and post operatively developed deep vein thrombosis (dvt).The patient was on aspirin and plavix for a recent coronary stent placement and was started on coumadin.The patient presented with gastrointestinal (gi) bleeding and was referred for ivc filter placement for contraindication to anticoagulation.The patient was prepped and draped in the usual sterile fashion.Vascular access was obtained using modified seldinger technique and a sheath was inserted into the right femoral vein.Angiography identified the merger of the iliac veins at the level of l3 and the merger of the renal veins at the level of t12 -l1.The inferior vena cava was of normal caliber without evidence of thrombus.The trapease ivc filter was then loaded and deployed at the level of l2.Repeat angiography showed good device opposition.
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