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

Catalog Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Pulmonary Embolism (1498); Thrombosis (2100); Perforation of Vessels (2135); Anxiety (2328)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown.As reported, 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 tilting of the filter, deep vein thrombosis and pulmonary embolism.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 product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The inferior vena cava (ivc) filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Deep vein thrombosis (dvt) occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.The presence of these clots do not represent a device malfunction.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Clinical factors that may have influenced these events include patient, pharmacological, lesion characteristics or other comorbidities.Without images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Additionally, the timing and mechanism of the reported filter tilt is unknown.Patient, technique or procedural factors may have contributed to the reported tilt.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/or manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.Please note that this is the initial/final report for this product.

Event Description

As reported by the 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 tilting of the filter, deep vein thrombosis and pulmonary embolism.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

Event: additional information received per the medical records indicate that the patient has a history of bilateral pulmonary embolism and extensive right lower extremity deep vein thrombosis.The filter was deployed via the patient's left femoral vein.It was placed below the renal veins.The patient tolerated the index procedure well.  the results of computed tomography (ct) scans done approximately ten years and six months after the index procedure indicate that the filter is tilted and marginates the inferior vena cava wall.The caudal apex of the filter abuts the posterolateral ivc wall.The cranial filter apex measures 1.4 cm above the level of the left renal vein and approximately 3.1 cm above the level of the right renal vein.The filter struts all extend beyond the ivc wall.The most anterior strut marginates the pancreatic head and the anteriolateral lateral strut marginates the duodenum.There were no fractured or bent struts visible.There was no evidence of ivc stenosis.Additional information received per the patient profile form (ppf) states that the patient experienced tilting of the filter and perforation of filter struts outside the inferior vena cava.The patient also experienced anxiety, loss of sleep, nightmares, mental anguish and irritability.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

Section b5: as reported, 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 tilting of the filter, deep vein thrombosis and pulmonary embolism.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.Additional information received per the medical records indicate that the patient has a history of bilateral pulmonary embolism and extensive right lower extremity deep vein thrombosis.The filter was deployed via the patient's left femoral vein.It was placed below the renal veins.The patient tolerated the index procedure well.The results of computed tomography (ct) scans done approximately ten years and six months after the index procedure indicate that the filter is tilted and marginates the inferior vena cava (ivc) wall.The caudal apex of the filter abuts the posterolateral ivc wall.The cranial filter apex measures 1.4 cm above the level of the left renal vein and approximately 3.1 cm above the level of the right renal vein.The filter struts all extend beyond the ivc wall.The most anterior strut marginates the pancreatic head and the anterolateral lateral strut marginates the duodenum.There were no fractured or bent struts visible.There was no evidence of ivc stenosis.Additional information received per the patient profile form (ppf) states that the patient experienced tilting of the filter and perforation of filter struts outside the inferior vena cava.The patient also experienced anxiety, loss of sleep, nightmares, mental anguish and irritability.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 (ivc) filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Deep vein thrombosis (dvt) occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.The presence of these clots do not represent a device malfunction.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Clinical factors that may have influenced these events include patient, pharmacological, lesion characteristics or other comorbidities.Without images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Additionally, the timing and mechanism of the reported filter tilt is unknown.Patient, technique or procedural factors may have contributed to the reported tilt.The brief also reported perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.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.The nightmares and sleeplessness that the patient experienced are likely related to the anxiety.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/or 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

After further review of additional information received, the following sections have been updated accordingly: b4, g4, g7, h1, h2, h4 and h6.Section b5: additional information received from the discovery form states that the patient had a history of blood clots.The patient is also stating that the filter tipped and because of the scar tissue the filter is now considered to be irretrievable.  additional information received per an amended discovery form (df) states that the patient is being treated for anxiety.After being advised that the filter was tilted, the medication dose was increased due to increased anxiety.After learning that the filter could not be removed the dose was increased again due to increased anxiety.As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, history includes bilateral pulmonary embolism, blood clots and extensive right lower extremity deep vein thrombosis.The filter was deployed below the renal veins.The patient tolerated the index procedure well.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting of the filter, deep vein thrombosis and pulmonary embolism.A ct scan, done approximately ten years and six months after implant, reveals the filter is tilted and marginates the inferior vena cava (ivc) wall.The caudal apex of the filter abuts the posterolateral ivc wall.The cranial filter apex measures 1.4 cm above the level of the left renal vein and approximately 3.1 cm above the level of the right renal vein.The filter struts all extend beyond the ivc wall.The most anterior strut marginates the pancreatic head and the anterolateral lateral strut marginates the duodenum.There were no fractured or bent struts visible.There was no evidence of ivc stenosis.Per the patient profile form (ppf), the patient reports tilting of the filter and perforation of filter struts outside the inferior vena cava, and due to scarring, the filter is irretrievable.The patient also reports being treated for anxiety, as well as experiencing loss of sleep, nightmares, mental anguish and irritability.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Post procedure pulmonary embolism is a known potential adverse event associated with the use of the ivc filters.These events may be related to excessive clot burden from underlying patient specific factors.Anxiety, nightmares and sleeplessness 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8127453
• MDR Text Key: 129150064
• Report Number: 1016427-2018-02352
• 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
• Report Date: 07/19/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0307272
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR