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

Model Number 466P306X

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

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Transient Ischemic Attack (2109); Perforation of Vessels (2135); Blood Loss (2597)

Event Date 08/01/2015

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.Complaint conclusion: 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, caval thrombosis and deep venous thrombosis (dvt).The patient¿s medical history, indication for the device implant and procedural details have not been provided.There is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.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.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, resulting in swelling/edema/bulging of the effected extremity (s).The inferior vena cava filter is not indicated for use in the prevention of deep vein thrombosis.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.A device malfunction has not been reported at this time.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, caval thrombosis and deep venous thrombosis (dvt).As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses.Pain and suffering.And other damages.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, caval thrombosis and deep venous thrombosis (dvt).As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses.Pain and suffering.And other damages.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately twelve years and seven months post implantation.The patient reports blood clots, clotting and or occlusion of the ivc.The patient also reports suffering from pain and swelling in both legs, muscle weakness, a transient ischemic attack (tia) approximately eleven years post implantation, cannot stand on feet for long, diminished and disruption of capacity to walk, dizziness, extreme bleeding due to use of blood thinners (coumadin and pradaxa), anxiety and depression knowing that the filter is full of clots and cannot be removed, and was told of the consequences if removed, twitches in face, fear of another stoke, severe swelling and pain and life threatening complications after subsequent surgery due to filter occlusion circulation issues.The patient further reports severe pain and swelling of the legs, fear and anxiety of ivc filter breaking off and clots forming or being released, fear of death, another tia or stroke, heavy, continuous and instant bleeding during the month, heavy periods, excessive cramping, extended bleeding with dental work or menstruation, loss of thought and focus, depression, limited time on feet, swelling and pain throughout the night, constant use of compression stockings, lack of appetite, blood pressure pills, in addition to anxiety, fear, loss of life expectancy diminished as well as quality of life, fear of heart and muscle degeneration or failure.

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, caval thrombosis and deep venous thrombosis (dvt).Approximately eleven years after the implantation, the patient experienced a transient ischemic attack (tia).Approximately twelve years and seven months after implantation, the patient became aware that they had developed blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The patient reported experiencing pain, bilateral leg swelling and muscle weakness.The patient also reported difficulty standing and walking, dizziness, anxiety and depression.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 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.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A 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.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Blood clots and thrombosis/occlusion within device 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 and thrombosis.Swelling of the legs does not represent a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.Due to the nature of the complaint, the reported pain, tia, weakness and dizziness experienced by the patient could not be confirmed and the exact cause could not be determined.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

As reported, the patient had placement of the trapease inferior vena cava (ivc) filter.The indication for filter insertion has not been provided.The filter malfunctioned including caval thrombosis and deep venous thrombosis (dvt).Per the patient profile form (ppf), the patient reports perforation of the ivc, blood clots, clotting and or occlusion of the inferior vena cava (ivc), pain and swelling in both legs, muscle weakness, a transient ischemic attack (tia), swelling of legs with severe pain, dizziness, extreme bleeding, anxiety and depression.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.Blood clots that develop in the veins of the leg or pelvis possibly accompanied by swelling of the effected limb, may be related to a condition called dvt.A 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.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt, nor does it prevent the formation of dvt or other clots (thrombosis).Tia, bleeding, pain, anxiety, muscle weakness, dizziness, anxiety and depression do not represent device malfunctions 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 department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, caval thrombosis and deep venous thrombosis (dvt).As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses.Pain and suffering.And other damages.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately twelve years and seven months post implantation.The patient reports blood clots, clotting and or occlusion of the inferior vena cava (ivc).The patient also reports suffering from pain and swelling in both legs, muscle weakness, a transient ischemic attack (tia) approximately eleven years post implantation; cannot stand on feet for long, diminished and disruption of capacity to walk, dizziness, extreme bleeding due to use of blood thinners (coumadin and pradaxa), anxiety and depression knowing that the filter is full of clots and cannot be removed, and was told of the consequences if removed; twitches in face, fear of another stroke, severe swelling and pain and life threatening complications after subsequent surgery due to filter occlusion circulation issues.The patient further reports severe pain and swelling of the legs, fear and anxiety of the ivc filter breaking off and clots forming or being released; fear of death, another tia or stroke, heavy, continuous and instant bleeding during the month, heavy periods, excessive cramping, extended bleeding with dental work or menstruation, loss of thought and focus, depression, limited time on feet, swelling and pain throughout the night, constant use of compression stockings, lack of appetite, blood pressure pills, in addition to anxiety, fear, loss of life expectancy diminished as well as quality of life, fear of heart and muscle degeneration or failure.According to the information received in the redacted-amended patient profile form (ppf), the patient additionally reports becoming aware of perforation of filter struts outside the ivc.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8462589
• MDR Text Key: 140278820
• Report Number: 1016427-2019-02650
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 45 YR