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| Catalog Number 466P306X |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Cellulitis (1768); Coagulation Disorder (1779); Edema (1820); Unspecified Infection (1930); Occlusion (1984); Pain (1994); Thrombosis (2100); Pressure Sores (2326); Bowel Perforation (2668)
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| Event Date 10/01/2013 |
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Event Type
Injury
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Manufacturer Narrative
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As reported, the patient was implanted with a trapease vena cava filter.The filter subsequently malfunctioned and caused injury, damage, to patient including, but not limited to deep vein thrombosis (dvt).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 continue to suffer significant medical expenses pain and suffering, and other damages.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The inferior 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.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Deep vein thrombosis (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).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.The presence of these clots do not represent a device malfunction.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.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 was implanted with a trapease® vena cava filter.The filter subsequently malfunctioned and caused injury, damage, to patient including, but not limited to deep vein thrombosis (dvt) 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 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 was implanted with a trapease inferior vena cava (ivc) filter.Per the medical records, fourteen days prior to the ivc filter implant, the patient was admitted to the hospital with altered mental status.The patient¿s history is significant for hiv, hepatitis c, depression, history of iv drug abuse, and hypertension.The patient was intubated to protect the airway upon admission to the emergency room.The indication for the filter implant was non-occlusive thrombus in the left femoral and popliteal vein and a contraindication to anticoagulation due to the development of a hematoma.The filter was implanted through a previously placed triple lumen catheter in the fright internal jugular vein and deployed below the level of the renal veins.A venogram confirmed there was no clot in the vena cava.The filter implant was then followed by the evacuation of a deep muscle hematoma of the left thigh.The filter subsequently malfunctioned and caused injury, damage, to patient including, but not limited to deep vein thrombosis (dvt).Per the patient profile form (ppf), there are blood clots, clotting and/or occlusion of the inferior vena cava (ivc).Approximately three and a half years after implantation, the patient was diagnosed with a deep vein thrombosis (dvt).The patient is also reports venous stasis ulcers and edema below the knee in both legs, foot infection and cellulitis, severe pain and needs a walker and a wheelchair to get around.The patient also reports the filter has moved to the left side of the abdomen.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.Blood clots, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Leg edema, ulcers of the extremities, cellulitis, pain and foot infection do not represent device malfunctions and may be related to underlying patient issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.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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The patient¿s history is significant for hiv, hepatitis c, depression, history of iv drug abuse, and hypertension.The patient was intubated to protect the airway upon admission to the emergency room.The indication for the filter implant was non-occlusive thrombus in the left femoral and popliteal vein and a contraindication to anticoagulation due to the development of a hematoma.The filter was implanted through a previously placed triple lumen catheter in the fright internal jugular vein and deployed below the level of the renal veins.A venogram confirmed there was no clot in the vena cava.The filter implant was then followed by the evacuation of a deep muscle hematoma of the left thigh.An x-ray of the left hip performed the day of the filter implant showed: marked flattening of the femoral head representing either pronounced chronic avascular necrosis or previous resection of the left femoral head with enlargement and erosive changes of the left acetabulum, most likely chronic, related to the changes involving the left femoral head.Septic arthritis is unlikely, given no erosive changes of the femoral head, although not excluded given the appearance of the left acetabulum, no evidence of an acute fracture of the left hip.The following day an aspiration of the left hip was performed.During the course of the hospitalization, one month, the patient was diagnosed with methicillin-sensitive staphylococcus aureus (mssa) bacteremia and sepsis, acute respiratory failure, pneumonia, left lower extremity dvt, infected wound of the left lower extremity and paroxysmal atrial fibrillation.There is no medical evidence to relate the ivc filter and the events of methicillin-sensitive staphylococcus aureus (mssa) bacteremia and sepsis, acute respiratory failure, pneumonia, infected wound of the left lower extremity, and paroxysmal atrial fibrillation.These events are related to the underlying patient condition at presentation to the hospital, specifically the degeneration and possible infection of the acetabular surface in the effected hip.These events will be non-complaints.
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Manufacturer Narrative
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As reported, the patient was implanted with a trapease inferior vena cava (ivc) filter.Per the medical records, history includes recent altered mental status (cause of admission), hiv, hepatitis c, depression, history of iv drug abuse, dvt (deep vein thrombosis) and hypertension.The patient was intubated upon admission to the er.The indication for filter was non-occlusive thrombus in the left femoral and popliteal vein with contraindication to anticoagulation due to a hematoma.The filter was deployed below the level of the renal veins.A venogram confirmed there was no clot in the vena cava.Then an evacuation of a deep muscle hematoma of the left thigh was performed.An x-ray of the left hip post filter implant revealed marked flattening of the femoral head, possibly chronic avascular necrosis.The following day, an aspiration of the left hip was performed.During the course of the filter implant hospitalization, one month, the patient was diagnosed with methicillin-sensitive staphylococcus aureus (mssa) bacteremia and sepsis, acute respiratory failure, pneumonia, left lower extremity dvt, infected wound of the left lower extremity and paroxysmal atrial fibrillation.The filter subsequently malfunctioned and caused injury, damage, to patient including, but not limited to deep vein thrombosis (dvt), perforation into small bowel, tilt, embedment into wall of ivc, dyspnea, lower extremity pain and discharge, edema, erythema, and difficulty walking.Per the patient profile form (ppf), the patient reports blood clots, clotting and/or occlusion of the ivc.Approximately three and a half years post implant, the patient was diagnosed with a dvt and filter migration.The patient also reports venous stasis ulcers and edema in both legs, below the knee, foot infection and cellulitis, severe pain, bow legged deformity, one leg becoming shorter than the other, and needs a walker and/or wheelchair to get around.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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.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.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.It was reported that there was perforation of the ivc; 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Ulcers of the extremities, leg edema, foot infection, cellulitis, pain, dyspnea, erythema, walking difficulty 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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