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| Model Number 466P306X |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Coagulation Disorder (1779); Occlusion (1984); Perforation (2001); Perforation of Vessels (2135); Blood Loss (2597)
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| Event Date 09/01/2017 |
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Event Type
Injury
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Manufacturer Narrative
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The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to filter perforation.The patient¿s medical history, procedural details or device indication have not been provided.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 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.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.With the limited information available and without the procedural films or post implant images to review the reported device perforation of the inferior vena cava could not be confirmed or further clarified.Given the limited information currently available for review, 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 department, 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 filter 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 continue to suffer significant medical expenses, pain and suffering, and other damages.
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Manufacturer Narrative
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The catalog number is unknown, if received it will be provided.Concomitant devices: unown wire, unknown introducer sheath, unknown dilator complaint conclusion: as reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have presented with bilateral lower extremity deep vein thrombosis (dvt) and pulmonary embolism (pe).The filter was implanted via the right common femoral vein and deployed with excellent approximation of the filter to the inferior vena cava (ivc) wall circumferentially at the level of l3.The patient is reported to have tolerated the procedure well.Approximately nine and a half years after the implantation, the patient reported having experienced a dvt event.Approximately eleven years and two months after the implantation, the patient became aware that the filter was associated with perforation of strut(s) outside the ivc, blood clots, clotting and/or occlusion of the ivc.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 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.The reported ivc perforation could not be confirmed without procedural films for review.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.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Blood clots and occlusion within the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.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 by the legal department, 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 filter 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 continue to suffer significant medical expenses, pain and suffering, and other damages.The following additional information was received per the patient¿s implant records: the patient had a history of bilateral lower extremity deep vein thrombosis (dvt) and pulmonary embolus.The filter was deployed under fluoroscopic guidance.A follow up venogram was performed and revealed excellent approximation of the filter to the wall of the vena cava circumferentially at approximately l3 vertebral body.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately eleven years and two months post implantation.The patient reports perforation of the filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting, and or occlusion of the ivc.The patient also reports suffering from a dvt approximately nine years and six months post implant placement.
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Event Description
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As reported by the legal department, 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 filter 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 continue to suffer significant medical expenses, pain and suffering, and other damages.The following additional information was received per the patient¿s implant records: the patient had a history of bilateral lower extremity deep vein thrombosis (dvt) and pulmonary embolus.The filter was deployed under fluoroscopic guidance.A follow up venogram was performed and revealed excellent approximation of the filter to the wall of the vena cava circumferentially at approximately l3 vertebral body.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately eleven years and two months post implantation.The patient reports perforation of the filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting, and or occlusion of the ivc.The patient also reports suffering from a dvt approximately nine years and six months post implant placement.According to the information received in the redacted/ammended patient profile form (ppf), the patient further reports suffering from psychological injuries or mental anguish related to the filter, in addition to shortness of breath, chest pain and numbness of the legs.
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Manufacturer Narrative
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Complaint conclusion: as reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have presented with bilateral lower extremity deep vein thrombosis (dvt) and pulmonary embolus (pe).The filter was implanted via the right common femoral vein and deployed at the level of l3 with excellent approximation of the filter to the vena cava wall.The patient is reported to have tolerated the procedure well.Approximately nine and a half years after filter implantation, the patient developed a dvt.Approximately eleven years and two months after the implantation, the patient became aware that filter strut(s) had perforated outside the inferior vena cava (ivc) and was associated with blood clots, clotting and/or occlusion of the ivc.The patient further reported having experienced psychological injuries and mental anguish associated with the filter; as well as shortness of breath (sob), chest pain and leg numbness.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 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.The reported ivc perforation could not be confirmed without procedural films for review.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.Blood clots and thrombosis/occlusion within the ivc do not represent a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.Due to the nature of the complaint, the reported chest pain and sob experienced by the patient could not be confirmed and the exact cause could not be determined.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, 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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Manufacturer Narrative
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It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter perforation.The patient became aware of perforation of the filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting, and or occlusion of the ivc, approximately eleven years and two months post implantation and experiencing a dvt approximately nine years and six months post implant placement.The patient also reports mental anguish related to the filter in addition to shortness of breath (sob), chest pain and leg numbness.Per the medical records provided, six days prior to the index procedure, the patient underwent placement of a left subclavian triple lumen central venous catheter, with a preoperative diagnosis of phlebosclerosis and chest pain.According to the implant record the patient had a history of bilateral lower extremity deep vein thrombosis (dvt) and pulmonary embolus.The filter was deployed under fluoroscopic guidance.A follow up venogram was performed and revealed excellent approximation of the filter to the wall of the vena cava circumferentially at approximately l3 vertebral body.Upon completion of filter insertion, fluoroscopic video sequences were obtained, revealing a patent inferior vena cava and the filter centered at the l2-3-disc interspace.The patient tolerated the procedure well.Approximately twelve years and five months after the filter was implanted, the patient underwent an abdominal computed tomography (ct) scan due to internal bleeding and to check the position of the filter.The scan reported the inferior vena cava filter below the level of the renal veins.The limbs of the filter were seen projecting outside the lumen of the ivc indicating penetration with no surrounding fluid or hematoma.The report noted this as a chronic finding of uncertain significance.Other incidental findings included multiple gallstones in the gallbladder, moderate degenerative changes in the lumbar spine, and infiltrate changes in the subcutaneous soft tissues of the abdominal wall, probably related to subcutaneous injections.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 trapease vena cava filter is indicated for use in the prevention of recurrent 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.The reported ivc perforation could not be confirmed without procedural films for review.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.Blood clots and thrombosis/occlusion within the ivc do not represent a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing comorbidities, pharmacological and vessel characteristics.Due to the nature of the complaint, the reported chest pain and sob and internal bleeding experienced by the patient could not be confirmed and the exact cause could not be determined, these events, as well as anxiety, do 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, unease and worry.These events 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 by the legal department, 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 filter 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 continue to suffer significant medical expenses, pain and suffering, and other damages.The following additional information was received per the patient¿s implant records: the patient had a history of bilateral lower extremity deep vein thrombosis (dvt) and pulmonary embolus.The filter was deployed under fluoroscopic guidance.A follow up venogram was performed and revealed excellent approximation of the filter to the wall of the vena cava circumferentially at approximately l3 vertebral body.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately eleven years and two months post implantation.The patient reports perforation of the filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting, and or occlusion of the ivc.The patient also reports suffering from a dvt approximately nine years and six months post implant placement.According to the information received in the redacted/ammended patient profile form (ppf), the patient further reports suffering from psychological injuries or mental anguish related to the filter, in addition to shortness of breath, chest pain and numbness of the legs.Per the medical records provided, six days prior to the index procedure, the patient underwent placement of a left subclavian triple lumen central venous catheter, with a preoperative diagnosis of phlebosclerosis and chest pain.The patient is reported to have tolerated the procedure well.Upon completion of filter insertion, fluoroscopic video sequences were obtained, revealing a patent inferior vena cava and the filter centered at the l2-3-disc interspace.Approximately twelve years and five months after the filter was implanted, the patient underwent an abdominal computed tomography (ct) scan due to internal bleeding and to check the position of the filter.The scan reported the inferior vena cava filter below the level of the renal veins.The limbs of the filter were seen projecting outside the lumen of the ivc indicating penetration with no surrounding fluid or hematoma.The report noted this as a chronic finding of uncertain significance.Other incidental findings included multiple gallstones in the gallbladder, moderate degenerative changes in the lumbar spine, and infiltrate changes in the subcutaneous soft tissues of the abdominal wall, probably related to subcutaneous injections.
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Search Alerts/Recalls
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