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| Catalog Number 466P306AU |
| Device Problems
Fracture (1260); Unintended Movement (3026)
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| Patient Problems
Cardiac Arrest (1762); Pulmonary Edema (2020); Anxiety (2328); Depression (2361)
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| Event Date 03/17/2016 |
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Event Type
Death
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Manufacturer Narrative
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This report is a follow up report to mfr number 9616099-2016-00331 that was submitted under the previous complaint handling software system.The information has been duplicated from the first report with additional information added.It was reported that a patient underwent implantation of a trapease inferior vena cava filter.The indication for the implant and the medical history of the patient have not been provided.It was reported that at some point after implant the filter fractured and migrated.The device was surgically removed during a procedure to remove a foreign body from the right ventricle and tricuspid repair, and then sent to pathology.The pathology report states, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter.The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen.The third portion is a single small wire, 1.5 cm in length.Additional information indicated that approximately two years after implant portions of the device were surgically removed from the heart.Approximately one month after the procedure to remove the device the patient expired due to complications related to the filter including cardiac arrest and acute pulmonary edema.There is currently no additional information available.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.Without procedural films for review, the reported filter fracture/separation and migration of the filter could not be confirmed and the exact cause could not be determined.The timing and mechanism of the fracture and migration are unknown at this time.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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 includes 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.Acute pulmonary edema and cardiac arrest are not representative of a device malfunction, with the limited information currently available it is not possible to determine what factors may have contributed to those events and the death of the patient.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 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 notice, following the death of the patient implanted with a trapease vena cava filter, it was removed by a pathologist.The notification from the pathologist to the patients attorney was received of a procedure involving removal of a foreign object in the right ventricle repair tricuspid.The report states, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter.The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen.The third portion is a single small wire, 1.5 cm in length.At the request of the surgeon, the specimen will be returned to the o.R.Who will return to the manufacturer." additional information was received that the device was implanted on (b)(6) 2014.After implantation, the ivc filter fractured and the fractured pieces/the entire device migrated to the other parts of the patient's body, including the heart.On (b)(6) 2016, the portions of the filter were surgically removed from the heart.On or about (b)(6) 2016, the patient died from complications related to the filter including cardiac arrest and acute pulmonary edema.Additional information received in the form of the device product code and lot number.
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Manufacturer Narrative
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The device has not been returned to the manufacturer, but was released to a biomedical storage facility, where it currently remains.Additional information was received indicated that after implantation, the ivc filter fractured and the fractured pieces/the entire device migrated to the other parts of the patient's body, including the heart.Approximately two years after the implant the portions of the filter were surgically removed from the heart.Approximately one month later the patient died from complications related to the filter including cardiac arrest and acute pulmonary edema.Additional information contained in court documents indicated that the patient was in a coma after a motorcycle accident and that the filter was implanted to prevent blood clots.It is unknown if the patient regained consciousness after the motorcycle accident or the condition of the patient leading up to the surgical removal of the device.The patient was prescribed insulin and another medication related to the patient¿s kidneys.A computerized tomography (ct) scan performed prior to the surgery showed that the filter was in the patient¿s heart.It was reported that, following the death of a patient implanted with a trapease vena cava filter, it was removed by a pathologist.The notification from the pathologist to the patient¿s attorney was received of a procedure involving removal of a foreign object in the right ventricle repair tricuspid.The report states, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter.The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen.The third portion is a single small wire, 1.5 cm in length.At the request of the surgeon, the specimen will be returned to the o.R.Who will return to the manufacturer." the device has not been returned to the manufacturer, but was released to a biomedical storage facility, where it currently remains.Additional information was received indicated that after implantation, the ivc filter fractured and the fractured pieces/the entire device migrated to the other parts of the patient's body, including the heart.Approximately two years after the implant the portions of the filter were surgically removed from the heart.Approximately one month later the patient died from complications related to the filter including cardiac arrest and acute pulmonary edema.Additional information contained in court documents indicated that the patient was in a coma after a motorcycle accident and that the filter was implanted to prevent blood clots.It is unknown if the patient regained consciousness after the motorcycle accident or the condition of the patient leading up to the surgical removal of the device.The patient was prescribed insulin and another medication related to the patient¿s kidneys.A computerized tomography (ct) scan performed prior to the surgery showed that the filter was in the patient¿s heart.There is currently no additional information available.The product was not returned for analysis.A review of the device history record (dhr) associated with lot 15964751 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Without procedural films for review, the reported filter fracture/separation and migration of the filter could not be confirmed and the exact cause could not be determined.The timing and mechanism of the fracture and migration are unknown at this time.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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 includes 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.Acute pulmonary edema and cardiac arrest are not representative of a device malfunction, with the limited information currently available it is not possible to determine what factors may have contributed to those events and the death of the patient.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 manufacturing process of the device; therefore no corrective action will be taken.
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Manufacturer Narrative
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After further review of additional information received.Additional medical records were received in reference to the patient¿s open heart surgery.The patient underwent open heart surgery for removal of foreign object from the right atrium and ventricle and tricuspid valve repair with annuloplasty and left subclavian placement of a temporary hemodialysis catheter.Surgical notes of the filter removal indicated that the filter was primarily in the right ventricle, with part of the filter protruding through the tricuspid valve and into the right atrium.On further exam it was noted that at least one of the wire prongs was endothelialized and scarred down into the ventricular septum and another wire was endothelialized mainly into the anterior leaflet of the tricuspid valve and papillary muscle.The filter was freed from the scar tissue meticulously, ensuring no damage to the valve or the papillary muscles.The filter was removed in totality, the patient tolerated the procedure well and left the operating suite in critical but stable condition.The post-operative course was uneventful other than some serosanguinous sternal incisional drainage, that tested negative for a wound infection.The patient was discharged home, eleven days later.One month after the heart surgery, the patient was brought to the emergency room via ambulance for complaints of shortness of breath on exertion.Approximately three and a half hours arrival the patient became diaphoretic, pale and was bradycardic.The patient was moved from the chair to a bed and was noted to be asystolic, cardiopulmonary resuscitation (cpr) was initiated.The patient was intubated and cpr carried out for approximately forty five minutes, the patient¿s spouse did not want cpr continued any longer, cpr was held and the patient was pronounced.The diagnosis provided at the time was cardiac arrest, end stage renal disease, acute pulmonary edema, and hyperkalemia. the medical records indicated that the patient also had a history of severe obstructive sleep apnea.
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Manufacturer Narrative
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After further review of additional information received, the following sections have been updated accordingly: event date is date of death.Describe event or problem: it was reported that, following the death of a patient implanted with a trapease vena cava filter, the filter was removed by a surgeon.At the request of the surgeon, the specimen will be returned to the operating room who will return to the manufacturer." the device has not been returned to the manufacturer, but was released to a biomedical storage facility, where it currently remains.Additional information was received indicated that after implantation, the ivc filter fractured and the fractured pieces/the entire device migrated to the other parts of the patient's body, including the heart.The patient¿s medical history has been provided and is significant for chronic stage v renal disease, diastolic congestive heart failure, hypertension, type ii diabetes mellitus, anemia and obesity.Three days prior to the index procedure, the patient was in a motorcycle accident resulting in multiple rib fractures, bruised lung, and brain swelling.Approximately one year and ten months after the index procedure, the patient was prepared for insertion of a perm-cath, under fluoroscopy.However, it was noted that the trapease filter was "floating." the procedure was aborted, and the patient was transferred to a different medical facility.The patient underwent open heart surgery for removal of foreign object from the right atrium and ventricle and tricuspid valve repair with annuloplasty and left subclavian placement of a temporary hemodialysis catheter.Surgical notes of the filter removal indicated that the filter was primarily in the right ventricle, with part of the filter protruding through the tricuspid valve and into the right atrium.On further exam it was noted that at least one of the wire prongs was endothelialized and scarred down into the ventricular septum and another wire was endothelialized mainly into the anterior leaflet of the tricuspid valve and papillary muscle.The filter was freed from the scar tissue meticulously, ensuring no damage to the valve or the papillary muscles.The filter was removed in totality, the patient tolerated the procedure well and left the operating suite in critical but stable condition.The post-operative course was uneventful other than some serosanguinous sternal incisional drainage, that tested negative for a wound infection.The patient was discharged home, eleven days later with home health services.The device was sent to pathology for analysis, the report states, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter.The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen.The third portion is a single small wire, 1.5 cm in length.Approximately one month later the patient was brought to the emergency room via ambulance for complaints of shortness of breath on exertion.Approximately three and a half hours arrival the patient became diaphoretic, pale and was bradycardic.The patient was moved from the chair to a bed and was noted to be asystolic, cardiopulmonary resuscitation (cpr) was initiated.The patient was intubated and cpr was carried out for approximately forty five minutes, the patient¿s spouse did not want cpr continued any longer, cpr was held and the patient was pronounced.The diagnosis provided at the time was cardiac arrest, end stage renal disease, acute pulmonary edema, and hyperkalemia.The death record noted the cause of death as acute pulmonary edema, diabetes mellitus and end stage renal disease.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.Without procedural films for review, the reported filter fracture/separation and migration of the filter could not be confirmed, and the exact cause could not be determined.The timing and mechanism of the fracture and migration are unknown at this time.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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 includes 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 death certificate listed the cause of death as acute pulmonary edema, diabetes and end stage renal disease.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 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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Af additional information received per the medical records indicate that approximately three years prior to the index procedure the patient presented for treatment.The patient was diagnosed on admission with gastro-intestinal bleeding, anemia, hyperglycemia with uncontrolled diabetes and malignant hypertension. a certificate of death was provided; however, the cause of death was not listed on the certificate.A substantial number of imaging scans were received.Any additional information obtained from these scans will be submitted upon receipt.Additional information is pending and will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Five photos of an unidentified procedure were received. no additional events were derived from these photos. it was reported that, following the death of a patient implanted with a trapease vena cava filter, the filter was removed by a surgeon.At the request of the surgeon, the specimen will be returned to the o.R.Who will return to the manufacturer." the device has not been returned to the manufacturer, but was released to a biomedical storage facility, where it currently remains.Additional information was received indicated that after implantation, the ivc filter fractured and the fractured pieces/the entire device migrated to the other parts of the patient's body, including the heart.The patient¿s medical history has been provided and is significant for chronic stage v renal disease, diastolic congestive heart failure, hypertension, type ii diabetes mellitus, anemia and obesity.New information received indicated that approximately three years prior to implant the patient was admitted to the hospital, the diagnosis on admission was gastro-intestinal bleed, anemia, hyperglycemia with uncontrolled diabetes and malignant hypertension.Three days prior to the index procedure, the patient was in a motorcycle accident resulting in multiple rib fractures, bruised lung, and brain swelling.Approximately one year and ten months after the index procedure, the patient was prepared for insertion of a perm-cath, under fluoroscopy.However, it was noted that the trapease filter was "floating." the procedure was aborted, and the patient was transferred to a different medical facility.The patient underwent open heart surgery for removal of foreign object from the right atrium and ventricle and tricuspid valve repair with annuloplasty and left subclavian placement of a temporary hemodialysis catheter.Surgical notes of the filter removal indicated that the filter was primarily in the right ventricle, with part of the filter protruding through the tricuspid valve and into the right atrium.On further exam it was noted that at least one of the wire prongs was endothelialized and scarred down into the ventricular septum and another wire was endothelialized mainly into the anterior leaflet of the tricuspid valve and papillary muscle.The filter was freed from the scar tissue meticulously, ensuring no damage to the valve or the papillary muscles.The filter was removed in totality, the patient tolerated the procedure well and left the operating suite in critical but stable condition.The post-operative course was uneventful other than some serosanguinous sternal incisional drainage, that tested negative for a wound infection.The patient was discharged home, eleven days later with home health services.The device was sent to pathology for analysis, the report states, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter.The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen.The third portion is a single small wire, 1.5 cm in length.Approximately one month later the patient was brought to the emergency room via ambulance for complaints of shortness of breath on exertion.Approximately three and a half hours after arrival the patient became diaphoretic, pale and was bradycardic.The patient was moved from the chair to a bed and was noted to be asystolic, cardiopulmonary resuscitation (cpr) was initiated.The patient was intubated and cpr was carried out for approximately forty five minutes, the patient¿s spouse did not want cpr continued any longer, cpr was held and the patient was pronounced.The diagnosis provided at the time was cardiac arrest, end stage renal disease, acute pulmonary edema, and hyperkalemia.The death record noted the cause of death as acute pulmonary edema, diabetes mellitus and end stage renal disease.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.Without procedural films for review, the reported filter fracture/separation and migration of the filter could not be confirmed, and the exact cause could not be determined.The timing and mechanism of the fracture and migration are unknown at this time.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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 includes 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 death certificate listed the cause of death as acute pulmonary edema, diabetes and end stage renal disease.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 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, following the death of a patient implanted with a trapease vena cava filter, the filter was removed by a surgeon.At the request of the surgeon, the specimen will be returned to the o.R.Who will return to the manufacturer." the device has not been returned to the manufacturer, but was released to a biomedical storage facility, where it currently remains.Additional information was received indicated that after implantation, the ivc filter fractured and the fractured pieces/the entire device migrated to the other parts of the patient's body, including the heart.The patient¿s medical history has been provided and is significant for chronic stage v renal disease, diastolic congestive heart failure, hypertension, type ii diabetes mellitus, anemia and obesity.New information received indicated that approximately three years prior to implant the patient was admitted to the hospital, the diagnosis on admission was gastro-intestinal bleed, anemia, hyperglycemia with uncontrolled diabetes and malignant hypertension.Three days prior to the index procedure, the patient was in a motorcycle accident resulting in multiple rib fractures, bruised lung, and brain swelling.Approximately one year and ten months after the index procedure, the patient was prepared for insertion of a perm-cath, under fluoroscopy.However, it was noted that the trapease filter was "floating." the procedure was aborted, and the patient was transferred to a different medical facility.The patient underwent open heart surgery for removal of foreign object from the right atrium and ventricle and tricuspid valve repair with annuloplasty and left subclavian placement of a temporary hemodialysis catheter.Surgical notes of the filter removal indicated that the filter was primarily in the right ventricle, with part of the filter protruding through the tricuspid valve and into the right atrium.On further exam it was noted that at least one of the wire prongs was endothelialized and scarred down into the ventricular septum and another wire was endothelialized mainly into the anterior leaflet of the tricuspid valve and papillary muscle.The filter was freed from the scar tissue meticulously, ensuring no damage to the valve or the papillary muscles.The filter was removed in totality, the patient tolerated the procedure well and left the operating suite in critical but stable condition.The post-operative course was uneventful other than some serosanguinous sternal incisional drainage, that tested negative for a wound infection.The patient was discharged home, eleven days later with home health services.The device was sent to pathology for analysis, the report states, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter.The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen.The third portion is a single small wire, 1.5 cm in length.Approximately one month later the patient was brought to the emergency room via ambulance for complaints of shortness of breath on exertion.Approximately three and a half hours after arrival the patient became diaphoretic, pale and was bradycardic.The patient was moved from the chair to a bed and was noted to be asystolic, cardiopulmonary resuscitation (cpr) was initiated.The patient was intubated and cpr was carried out for approximately forty five minutes, the patient¿s spouse did not want cpr continued any longer, cpr was held and the patient was pronounced.The diagnosis provided at the time was cardiac arrest, end stage renal disease, acute pulmonary edema, and hyperkalemia.The death record noted the cause of death as acute pulmonary edema, diabetes mellitus and end stage renal disease.Additional information was received in the form of photos of what appears to be open heart procedure with a patient on bypass.There are no patient identifiers on the photos and there was no narrative provided.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.Without procedural films for review, the reported filter fracture/separation and migration of the filter could not be confirmed, and the exact cause could not be determined.The timing and mechanism of the fracture and migration are unknown at this time.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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 includes 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 death certificate listed the cause of death as acute pulmonary edema, diabetes and end stage renal disease.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 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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Additional information received per the medical records indicate that three years prior to the index procedure the patient had knee surgery.Six months after the index procedure, the patient was seen at a medical facility for muscle weakness and was diagnosed with polymyopathy.The patient was also treated for depression and anxiety.The records noted that the patient¿s end-stage chronic kidney disease was treated with hemodialysis.As reported, the patient had implant of a trapease inferior vena cava (ivc) filter.History includes chronic stage v renal disease, diastolic congestive heart failure, hypertension, type ii diabetes mellitus, anemia, knee surgery and obesity.Three days prior to the index procedure, the patient was in a motorcycle accident.The accident caused the patient to sustained multiple rib fractures, bruised lung, and brain swelling.The indication for filter implant was a coma following a motorcycle accident, and the filter was implanted to prevent blood clots.It is unknown if the patient regained consciousness after the motorcycle accident and filter implantation.Six months after the index procedure, the patient was seen for muscle weakness and was diagnosed with polymyopathy.The patient was also treated for depression and anxiety.The records noted that the patient¿s end-stage chronic kidney disease was treated with hemodialysis.Approximately two years post implant, there was removal of the ivc filter from the right ventricle repair.The patient underwent open heart surgery for removal of foreign object from the right atrium and ventricle and tricuspid valve repair with annuloplasty and left subclavian placement of a temporary hemodialysis catheter.Surgical notes of the filter removal indicated that the filter was primarily in the right ventricle, with part of the filter protruding through the tricuspid valve and into the right atrium.On further exam it was noted that at least one of the wire prongs was endothelialized and scarred down into the ventricular septum and another wire was endothelialized mainly into the anterior leaflet of the tricuspid valve and papillary muscle.The filter was freed from the scar tissue meticulously, ensuring no damage to the valve or the papillary muscles.Per the pathology report, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter.The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen.The third portion is a single small wire, 1.5 cm in length.¿ approximately one year and ten months after the index procedure, the patient was prepared for insertion of a perma-cath, under fluoroscopy.However, it was noted that the trapease filter was "floating." the procedure was aborted, and the patient was transferred to a different medical facility.A ct scan revealed the ivc filter had fractured and the device migrated to the other parts of the patient's body, including the heart.Approximately one month later the patient died from complications related to the filter including cardiac arrest and acute pulmonary edema.The death certificate lists cause of death as acute pulmonary edema, diabetes mellitus and end stage renal disease.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.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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.Acute pulmonary edema and cardiac arrest, while not specifically listed in the ifu, are known potential events that contribute to death associated with the ivc filters.In this case, there was migration of the filter to the chambers of the heart, effecting the performance of the cardiac structures that may have contributed to the pulmonary edema and cardiac arrest.However, it is to be noted that this patient had a long standing history of end stage kidney disease, and needed hemodialysis, there by making his potential for pulmonary edema much higher than the average population.Anxiety and depression 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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A large zipped file was received.The files are unable to be opened.Any additional information obtained from these zipped files will be submitted within 30 days of retrieval.
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Manufacturer Narrative
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Radiological images for this patient have been received.Any additional information obtained from these images will be submitted within 30 days of receipt.
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Manufacturer Narrative
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After further review of additional information received, the following sections have been updated accordingly.As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of insulin-dependent diabetes mellitus (dm) with diabetic polyneuropathy and renal insufficiency (requiring medication).Further history included gastrointestinal (gi) bleeding from gastritis requiring blood transfusions, hematospermia, anemia, obesity, sleep apnea, congestive heart failure with hypertrophy, essential hypertension and secondary hyperparathyroidism (of renal origin).The medical records further indicate that the patient was often non-compliant with their dm and hypertension prescribed therapies.The patient¿s medical records also note that the patient had been absent from work on a number of occasions related to their ongoing health issues.The patient is also reported to have been recently involved in a motorcycle accident in associated with hypoglycemia and was in a coma and required prolonged mechanical ventilation and dialysis.According to the patient¿s spouse, the indication for the filter placement was reported to be for the prevention of blood clots.Six months after the implantation, the patient was treated for depression and anxiety.Approximately one year and ten months after implantation, the patient became aware that the filter had fractured and that fragments had migrated to other areas including the patient¿s heart.A computerized tomography (ct) scan that revealed the filter fragments in the patient¿s heart.The patient underwent surgical removal of three filter fragments from the right ventricle; along with a tricuspid valve repair with annuloplasty.Surgical notes of the filter removal indicated that the filter was primarily in the right ventricle, with part of the filter protruding through the tricuspid valve and into the right atrium.On further exam it was noted that at least one of the wire prongs was endothelialized and scarred down into the ventricular septum and another wire was endothelialized mainly into the anterior leaflet of the tricuspid valve and papillary muscle.The filter was freed from the scar tissue meticulously, ensuring no damage to the valve or the papillary muscles.The filter was removed in totality, the patient tolerated the procedure well and left the operating suite in critical but stable condition.Pathology results associated with the three removed filter fragments indicated that the largest piece of metal wire had an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter.The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen.The third portion is a single small wire, 1.5 cm in length.Approximately one month later, the patient presented to hospital with shortness of breath via ambulance.Approximately three and a half hours after arrival, the patient decompensated and went into cardiac arrest and acute pulmonary edema (pe).Of note, prior to the cardiac arrest, the patient was noted to have leukocytosis and was hyperkalemic and hyperglycemic; along with elevated brain natriuretic peptide levels.The provided death certificate indicated that the immediate cause of death was acute pe with leading causes of type ii dm and end stage renal disease.An autopsy was not performed.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 inferior vena cava (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 procedural films for review, the reported filter fracture and migration events could not be confirmed and the exact cause could not be determined.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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 ivc 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.Due to the nature of the complaint, the reported cardiac arrest and acute pulmonary edema events 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 and depression 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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Additional patient information was received per the patient¿s social security disability records.Medical history prior to the motor vehicle accident (mva) includes renal disease, hypertension, dm, sleep apnea and morbid obesity.Medical conditions claimed also include kidney failure, coma for three months, muscle apathy and pain this patient¿s status post motor vehicle accident (mva) resulting in blunt chest trauma, respiratory failure, pulmonary contusions, rib fractures, pneumothorax, closed head injury, acute kidney injury and extensive road rash.The inferior vena cava filter was placed secondary to immobility and inability to coagulate.The patient was admitted for comprehensive inpatient rehabilitation subsequent to the hospitalization following the mva.A tracheostomy was performed secondary to lengthy need for ventilation support.Hemodialysis was completed through an implanted central venous access catheter during hospitalization and rehabilitation. three months after the index procedure, the patient was diagnosed with polyneuropathy and myopathy.The records state that extended hospitalization resulted in the critical illness polyneuropathy and critical illness myopathy seven months after the index procedure, the patient had placement of a peritoneal dialysis catheter for end stage renal disease, secondary to a motor vehicle crash complicated by acute renal failure that progressed to end stage renal failure.
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Manufacturer Narrative
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After further review of additional information received, the following sections have been updated accordingly: date of report, date rec¿d by mfr, pma/510k, type of reportable event and if follow-up, what type.Event: it was reported that, following the death of a patient implanted with a trapease vena cava filter, the filter was removed by a pathologist.The notification from the pathologist to the patient¿s attorney was received of a procedure involving removal of a foreign object in the right ventricle repair tricuspid.The report states, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter.The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen.The third portion is a single small wire, 1.5 cm in length.At the request of the surgeon, the specimen will be returned to the operating room who will return to the manufacturer." the device has not been returned to the manufacturer, but was released to a biomedical storage facility, where it currently remains.Additional information was received indicated that after implantation, the ivc filter fractured and the fractured pieces/the entire device migrated to the other parts of the patient's body, including the heart.Approximately two years after the implant the portions of the filter were surgically removed from the heart.Approximately one month later the patient died from complications related to the filter including cardiac arrest and acute pulmonary edema.The patient¿s medical history has been provided and is significant for chronic stage v renal disease, diastolic congestive heart failure, hypertension, type ii diabetes mellitus, anemia and obesity.Three days prior to the index procedure, the patient was in a motorcycle accident.The accident caused the patient to sustained multiple rib fractures, bruised lung, and brain swelling.The patient was noted to be non-compliant with physician follow ups and visits.Approximately one year and ten months after the index procedure, the patient was prepared for insertion of a perm-cath, under fluoroscopy.However, it was noted that the trapease filter was "floating." the procedure was aborted, and the patient was transferred to a different medical facility.Subsequently the patient had cardiac surgery.The death record noted the cause of death as acute pulmonary edema, diabetes mellitus and end stage renal disease.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.Without procedural films for review, the reported filter fracture/separation and migration of the filter could not be confirmed, and the exact cause could not be determined.The timing and mechanism of the fracture and migration are unknown at this time.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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 includes 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 death certificate listed the cause of death as acute pulmonary edema, diabetes and end stage renal disease.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 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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Additional information received per the medical records indicate that the patient has a history of chronic stage v renal disease, diastolic congestive heart failure, hypertension, type ii diabetes mellitus, anemia and obesity.Three days prior to the index procedure, the patient was in a motorcycle accident.The accident caused the patient to sustained multiple rib fractures, bruised lung, and brain swelling.The patient was noted to be non-compliant with physician follow ups and visits.Approximately one year and ten months after the index procedure, the patient was prepared for insertion of a perm-cath, under fluoroscopy.However, it was noted that the trapease filter was "floating." the procedure was aborted, and the patient was transferred to a different medical facility.Subsequently the patient had cardiac surgery.Additional information received per the death record states that the cause of death was acute pulmonary edema, diabetes mellitus and end stage renal disease.Additional information is pending and will be submitted within 30 days of receipt.
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