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

Model Number 466P306AU

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

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Arteriosclerosis (1722); Renal Failure (2041); Anxiety (2328); No Code Available (3191)

Event Date 04/09/2016

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent a surgical procedure to implant an trapease permanent vena cava filter for the treatment of pulmonary embolisms and deep venous thrombosis (dvt).The device was implanted into the patient¿s right internal jugular vein.The device was positively identified by the patient¿s medical records.On or about five years and eleven months later, the patient had a computerized tomography (ct) scan done on the abdominal region due to pains in the area.The inferior vena cava (ivc) filter was noted to be present and the patient was diagnosed with sclerosis present within the aorta.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the optease installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life- threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside his body.The product was not returned for analysis.Additionally, as the sterile lot number was not available, the device history record (dhr) review could not 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.Abdominal pain also does not represent a malfunction of the device.Aortic sclerosis is defined as calcification and thickening of a trileaflet aortic valve in the absence of obstruction of ventricular outflow.Clinical factors that may have influenced the events may include patient, pharmacological, or other comorbidities and are not necessarily related to the implantation of the filter.Without available films or medical records for review we are unable to confirm correlation of the related complaints with the device.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.

Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease retrievable vena cava filter for the treatment of pulmonary embolisms and deep venous thrombosis (dvt).The device was implanted into the patient¿s right internal jugular vein.The device was positively identified by the patient¿s medical records.On or about five years and eleven months post implant, the patient had a computerized tomography (ct) scan done on the abdominal region due to pains in the area.The inferior vena cava (ivc) filter was noted to be present and the patient was diagnosed with sclerosis present within the aorta.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the trapease installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life- threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside his body.

Manufacturer Narrative

Please note: the patient also experienced aortic sclerosis but there is no available code.Complaint conclusion: as reported, the patient underwent implantation of a cordis inferior vena cava (ivc) filter, the medical records indicate that an optease filter was implanted; however, the product number provided corresponds with a trapease device.Per the medical records, the patient had a history of deep vein thrombosis (dvt), shortness of breath and hematuria, secondary to chronic renal failure being treated with long term hemodialysis.During the filter placement procedure via the right internal jugular vein, the filter was deployed below the inflow of the renal veins.On the dame day, the patient received a lung scan which indicated that the patient had multiple small segmental matched defects scattered through both lungs.There was also central retention of tracer indicating an element of chronic obstructive pulmonary disorder (copd).Approximately five years and eleven months post implant, the patient had a computerized tomography (ct) scan done on the abdominal region due to pains in the area.The inferior vena cava (ivc) filter was noted to be present and the patient was diagnosed with sclerosis present within the aorta.According to the medical records, received, there was atrophy of the right kidney noted in the scan and cysts within both kidneys.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside the body.Approximately two years post implantation, the medical records note that the patient had pe with the filter.Per the patient profile form (ppf), the patient is suffering from anxiety, mental anguish 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.Pe (pulmonary embolus) do not represent a device malfunction.Aortic stenosis is not a product malfunction and may be related to underlying patient factors, specifically chronic renal failure.Renal failure is not a device malfunction, there is no evidence that the filter has contributed to this chronic medical condition.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.

Event Description

Please see the ed and compare - as reported by the legal brief, the patient underwent a surgical procedure to implant a trapease retrievable vena cava filter for the treatment of pulmonary embolisms (pe) and deep venous thrombosis (dvt).The device was positively identified by the patient¿s medical records.On or about five years and eleven months post implant, the patient had a computerized tomography (ct) scan done on the abdominal region due to pains in the area.The inferior vena cava (ivc) filter was noted to be present and the patient was diagnosed with sclerosis present within the aorta.According to the medical records, received, there was atrophy of the right kidney noted in the scan and cysts within both kidneys.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.The patient also as of the present had end stage renal disease and is in hemodialysis.As the result of the trapease installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life- threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside the body.The following additional information received per the medical records indicate that the patient had a history of deep vein thrombosis (dvt), shortness of breath and hematuria.During the filter placement procedure via the right internal jugular vein, the filter was deployed below the inflow of the renal veins.On the dame day, the patient received a lung scan which indicated that the patient had multiple small segmental matched defects scattered through both lungs.There was also central retention of tracer indicating an element of chronic obstructive pulmonary disorder (copd).Approximately two years post implantation, the medical records note that the patient had had pe with the filter.There is no information available on the pe.According to the additional information received in the patient profile form (ppf), the patient is suffering from anxiety, mental anguish and depression.

• 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
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6893131
• MDR Text Key: 87324835
• Report Number: 9616099-2017-01455
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2017
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR