MAUDE Adverse Event Report: TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306AU

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100); Stenosis (2263); Thromboembolism (2654); No Code Available (3191); Thrombosis/Thrombus (4440)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but no limited to, blood clots and deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.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 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.The development of blood clots do not represent a device malfunction.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).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.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.

Event Description

As reported by the legal brief, the patient underwent placement of defendants' trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots and deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.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 injury and damages to the patient, including, but not limited to, blood clots and deep vein thrombosis (dvt).The patient is also reported to have experienced blood clots, clotting, and/or occlusion of the ivc and a stroke.The patient reported that it has taken away their language and the ability to talk to people.The indication for the filter implant was deep vein thrombosis (dvt).The patient also had a history of pneumonia and left cerebral shunt placement.During the implantation of the ivc filter via right femoral vein, the filter was deployed into the infrarenal ivc without any complications.A single digital spot was performed to confirm it was in good position.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 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.Without films of the index procedure or post implant imaging, the reported blood clots, clotting and/or occlusion of the ivc could not be confirmed or further clarified at this time.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could not be confirmed.The patient reported experiencing a stroke, it was not reported if the stroke was embolic or hemorrhagic in nature.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Review of the information provided does not suggest that there is 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.

Manufacturer Narrative

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 injury and damages to the patient, including, but not limited to, blood clots and deep vein thrombosis (dvt).The patient is reported to have experienced blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).The patient became aware of the alleged events approximately one year and one-month post implantation of the ivc filter.It has not been reported how the patient became aware of these events.The indication for the filter placement was a history of dvt.The patient also had a history of pneumonia, severe headaches with blurred vision and a previously placed left ventriculo-peritoneal (vp) shunt.The filter was placed via the right femoral vein and deployed in the infra-renal ivc.A single digital spot was performed to confirm its position.There were no reported complications and the findings noted that the ivc and the renal veins are patent and the filter is seen to be in good position.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 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.Without films of the index procedure or post implant imaging, the reported blood clots, clotting and/or occlusion of the ivc could not be confirmed or further clarified at this time.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could not be confirmed.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Review of the information provided does not suggest that there is 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.

Manufacturer Narrative

The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter due to their history of deep vein thrombosis (dvt).The patient also has a history of pneumonia and left cerebral shunt placement.During the implantation of the ivc filter via right femoral vein, the filter was deployed into the infrarenal ivc without any complications.A single digital spot was performed to confirm it was in good position.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events approximately one year and one-month post implantation of the ivc filter.The patient reports to suffer from blood clots, clotting, and/or occlusion of the ivc.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.According to the information received in the amended ppf, the patient reports having had a stroke and it taking their language and ability to talk to people.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

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 blood clots and deep vein thrombosis (dvt).Additional information indicated that there was filter tilt, caval thrombosis, thrombosis/embolism and inferior vena cava (ivc) stenosis.The patient is also reported becoming aware of blood clots, clotting, and/or occlusion of the ivc and a stroke approximately thirteen months post implant.The patient reported that it has taken away their language and the ability to talk to people.The indication for the filter implant was deep vein thrombosis (dvt).The patient also had a history of pneumonia and left cerebral shunt placement.During the implantation of the ivc filter via right femoral vein, the filter was deployed into the infrarenal ivc without any complications.A single digital spot was performed to confirm it was in good position.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 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.Without films of the index procedure or post implant imaging, the reported blood clots, clotting and/or occlusion of the ivc could not be confirmed or further clarified at this time.Ivc stenosis, blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient, vessel characteristics and pharmacological factors may have contributed to these events.The patient reported experiencing a stroke, it was not reported if the stroke was embolic or hemorrhagic in nature.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Without imaging available for review the event could not be confirmed nor a cause attributed.Review of the information provided does not suggest that there is 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.

Event Description

As reported by an additional legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to filter tilt, caval thrombosis, thrombosis/embolism and inferior vena cava (ivc) stenosis.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, loss of enjoyment of life and other damages.

Manufacturer Narrative

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 blood clots and deep vein thrombosis (dvt).Additional information indicated that there was filter tilt, caval thrombosis, thrombosis/embolism and inferior vena cava (ivc) stenosis.The patient is also reported becoming aware of blood clots, clotting, and/or occlusion of the ivc and a stroke approximately thirteen months post implant.The patient reported that it has taken away their language and the ability to talk to people.The patient also reports anxiety related to the filter.The indication for the filter implant was deep vein thrombosis (dvt).The patient also had a history of pneumonia and left cerebral shunt placement.During the implantation of the ivc filter via right femoral vein, the filter was deployed into the infrarenal ivc without any complications.A single digital spot was performed to confirm it was in good position.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 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.Without films of the index procedure or post implant imaging, the reported blood clots, clotting and/or occlusion of the ivc could not be confirmed or further clarified at this time.Ivc stenosis, blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient, vessel characteristics and pharmacological factors may have contributed to these events.The patient reported experiencing a stroke, it was not reported if the stroke was embolic or hemorrhagic in nature.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Without imaging available for review the event could not be confirmed nor a cause attributed.Review of the information provided does not suggest that there is 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.

Event Description

As reported by the legal brief, 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, blood clots and deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter for a history of deep vein thrombosis (dvt).The patient also had a history of pneumonia and left cerebral shunt placement.During the implantation of the ivc filter via right femoral vein, the filter was deployed into the infrarenal ivc without any complications.A single digital spot was performed to confirm it was in good position.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events approximately one year and one-month post implantation of the ivc filter.The patient reports to suffer from blood clots, clotting, and/or occlusion of the ivc.According to the information received in the amended ppf, the patient reports having had a stroke and it taking the patient's language and ability to talk to people.The patient further experienced anxiety related to the filter.As reported by an additional legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to filter tilt, caval thrombosis, thrombosis/embolism and inferior vena cava (ivc) stenosis.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 7373514
• MDR Text Key: 103559669
• Report Number: 1016427-2018-01282
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17222042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK 0.035 WIRE; UNK 22G MICROPUNCTURE NEEDLE; UNK 6F SHEATH; UNK INTRODUCER SHEATH
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 38 YR