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Catalog Number 466P306X |
Device Problem
Insufficient Information (3190)
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Patient Problems
Internal Organ Perforation (1987); Perforation of Vessels (2135)
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Event Date 10/10/2020 |
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 including, but not limited to organ perforation.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 organ perforation.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.
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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 organ perforation.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient was reported to have a history of right leg deep vein thrombosis (dvt), and subsequently developed shortness of breath which revealed pulmonary embolus (pe); therefore, placement of the inferior vena cava (ivc) filter was indicated.The patient was prepped and draped in the supine position and a needle was inserted in the right common femoral vein, followed by a guidewire.Under fluoroscopy, the l2-l3 vertebral bodies were identified and a venogram was performed at this level, verifying the location above the bifurcation and below the left renal vein.The trapease was deployed at this level without difficulty.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, perforation of struts into organs becoming aware of these events approximately thirteen years and three months after the filter implantation, and further experienced anxiety related to the filter.
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Manufacturer Narrative
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As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the implant records, the indication was acute dvt (deep vein thrombosis) and pe (pulmonary embolus).A venocavogram located the renal veins and assessed the caliber of the ivc.The filter was successfully deployed in an infrarenal position.There were no reports of complications.The filter subsequently malfunctioned including perforation.Per the patient profile form (ppf), the patient reports ivc and organ perforation and anxiety related to 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 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 and organ 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.Anxiety does 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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Additional information was received per an amended patient profile form (ppf).The patient reported that they continue to experience "lots of constant pain." the patient went on to state that they cannot lay down properly or really sleep because they can never get comfortable.This is said to have started a couple of years ago.
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Manufacturer Narrative
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As reported a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused organ perforation.The patient reported becoming aware of perforation of filter struts outside the inferior vena cava (ivc) and into organs approximately thirteen years and three months post implant.The patient also reported anxiety related to the filter.According to the implant record the patient had a history of right leg deep vein thrombosis (dvt), and subsequently developed shortness of breath which revealed pulmonary embolus (pe); therefore, placement of the inferior vena cava (ivc) filter was indicated.The filter was placed via the right common femoral vein and deployed above the bifurcation and below the left renal vein without difficulty.The patient tolerated the procedure well.The patient subsequently reported experiencing ¿lots of constant pain¿.Going on to say that, starting a couple of years ago, they cannot lay down properly or really sleep because they can never get comfortable.The product remains implanted and unavailable for analysis, the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The trapease ivc filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.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.Without procedural films or post implant imaging available for review, the reported organ perforation could not be confirmed or further clarified.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
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Search Alerts/Recalls
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