MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Edema (1820); Occlusion (1984); Perforation (2001); Renal Failure (2041); Thrombosis (2100); Urinary Retention (2119); Perforation of Vessels (2135)

Event Date 05/12/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to deep vein thrombosis (dvt), pulmonary embolism (pe) and filter perforation.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As further proximate results, the patient has suffered and will continue to suffer significant medical expenses, pain, and suffering, and other damages.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The inferior vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Deep vein thrombosis (dvt) occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.The presence of these clots do not represent a device malfunction.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Without procedural films available for review, the reported perforation could not be confirmed.With the information available it is not possible to draw a clinical conclusion to the reported event, and the exact cause could not be determined.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.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 trapease vena cava filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to deep vein thrombosis ( dvt), pulmonary embolism (pe) and 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 results, the patient has suffered and will continue to suffer significant medical expenses, pain, and suffering, and other damages.

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 having a history of pulmonary embolus (pe), deep venous thrombosis (dvt), and at the time a recent episode of recurrent symptoms with possible recurrent pe.During implantation of the filter via the right common femoral vein, the filter was successfully deployed with the tip located just below the renal veins.There were no complications.According to the information received in the patient profile form (ppf), the patient became aware of the alleged events sometime post implantation and the patient reports having perforation of filter strut(s) outside the ivc, pulmonary embolism, blood clots, clotting, and/or occlusion of ivc.In addition, the patient states to suffer from severe edema, pain at insertion site, kidney failure, and bladder retention.As reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.Per the medical records, the patient underwent placement of the inferior vena cava (ivc) filter due to having a history of pulmonary embolus (pe), deep venous thrombosis (dvt), and at the time a recent episode of recurrent symptoms with possible recurrent pe.During implantation of the filter via the right common femoral vein, the filter was successfully deployed with the tip located just below the renal veins.There were no complications.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to deep vein thrombosis (dvt), pulmonary embolism (pe) and filter perforation.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the ivc, pulmonary embolism, blood clots, clotting, and/or occlusion of ivc.In addition, the patient states that they have been told the filter has caused: severe edema, pain at insertion site, kidney failure, and bladder retention.The filter remains implanted; thus, unavailable for analysis.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.It was reported that there was perforation of the ivc and adjacent structures; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots, pulmonary embolism and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Edema, implant site pain, kidney failure, and bladder retention 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.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.

Manufacturer Narrative

According to the information received via phase 2 discovery form, the patient states to have suffered from dvt, swelling, pain, pulmonary embolism, perforation, and have been on lovenox treatment post implantation of the ivc filter.Corrected data: product code.As reported, the patient had placement of trapease inferior vena cava (ivc) filter.Per the medical records, history includes pulmonary embolus (pe), deep venous thrombosis (dvt), and an acute possible recurrent pe.During implantation, the filter was successfully deployed with the tip located just below the renal veins.There were no complications.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to deep vein thrombosis (dvt), pulmonary embolism (pe) and filter perforation.Per the patient profile form (ppf), the patient reports having perforation of filter strut(s) outside the ivc, pulmonary embolism, blood clots, clotting, and/or occlusion of ivc.In addition, the patient also reports severe edema, pain at insertion site, kidney failure, and bladder retention.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.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.Edema, kidney failure and bladder retention while not specifically listed in the device ifu, are known event associated to the use of the filter device and may be related to the reported clotting events.Pain does 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.

Event Description

As reported by the legal brief, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to deep vein thrombosis ( dvt), pulmonary embolism (pe) and 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 results, the patient has suffered and will continue to suffer significant medical expenses, 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 due to having a history of pulmonary embolus (pe), deep venous thrombosis (dvt), and at the time a recent episode of recurrent symptoms with possible recurrent pe.During implantation of the filter via the right common femoral vein, the filter was successfully deployed with the tip located just below the renal veins.There were no complications.According to the information received in the patient profile form (ppf), the patient became aware of the alleged events sometime post implantation and the patient reports having perforation of filter strut(s) outside the ivc, pulmonary embolism, blood clots, clotting, and/or occlusion of ivc.In addition, the patient states that they have been told the filter has caused: severe edema, pain at insertion site, kidney failure, and bladder retention.According to the information received via phase 2 discovery form, the patient states to have suffered from dvt, swelling, pain, pulmonary embolism, perforation, and have been on lovenox treatment post implantation of the ivc filter.According to the updated discovery form, the patient received the ivc filter for pulmonary embolism and dvt.Medical conditions and treatments alleged to be attributable to the implanted ivc filter include: dvt with swelling, pain and lovenox treatment; pulmonary embolism; perforation and other unspecified conditions involving pain and swelling.The patient further reports past and future emotional distress; past and future loss of enjoyment of life, and other consequential damages as allowed by law.

Manufacturer Narrative

As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical record, filter placement was due to history of pulmonary embolus (pe), deep venous thrombosis (dvt), and recent possible recurrent pe.During implantation, the filter was deployed with the tip located just below the renal veins.There were no complications.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to deep vein thrombosis (dvt), pulmonary embolism (pe) and filter perforation.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the ivc, pulmonary embolism, blood clots, dvt, clotting, and/or occlusion of ivc.The patient also reports severe edema, pain at insertion site, kidney failure, anxiety and bladder retention.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.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Post procedural pulmonary embolism is a known potential event associated with the filter device, patent specific issues, specifically the underlying causes of thrombus formation, may contribute to these events.Kidney failure, edema, bladder retention anxiety and pain 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: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7580481
• MDR Text Key: 110447642
• Report Number: 1016427-2018-01523
• Device Sequence Number: 1
• Product Code: DTK
• 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,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 69 YR