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

Model Number 466P306X

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

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Coagulation Disorder (1779); Death (1802); Edema (1820); Occlusion (1984); Thrombosis (2100)

Event Date 12/28/2017

Event Type  Death  

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, 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, dvt, and pulmonary embolism, directly and proximately causing cardiac arrest and death.As a direct and proximate result of these filter malfunctions, the patient suffered fatal injuries, damages, and untimely death.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 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).Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported event.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.Without medical records available for review, the exact cause of cardiac arrest is unable to be determined.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 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, blood clots, dvt, and pulmonary embolism, directly and proximately causing cardiac arrest and death.As a direct and proximate result of these filter malfunctions, the patient suffered fatal injuries, damages, and untimely death.

Manufacturer Narrative

The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter because of a history of recurrent left lower extremity dvt and pe while therapeutic on coumadin.The patient also has a history of left knee surgery, hammertoe repair, sleep apnea, depression, arthritis, renal stones, diabetes mellitus, gastroesophageal reflux disease, pulmonary hypertension and occasional shortness of breath.During ivc filter implantation via right femoral vein, the filter was positioned and deployed at a level below the renal veins without any complications.According to the information received in the patient profile form (ppf), sometime post implantation of the ivc filter, the patient suffered blood clots, clotting, and/or occlusion of the ivc, dvt, persistent lower extremity edema, chest pain, shortness of breath with exertion, feelings of hopelessness, doom, and helplessness in not being able to perform normal duties.Neither the autopsy report nor death certificate are available at this time.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.Per the medical records, the patient underwent placement of the inferior vena cava (ivc) filter because of a history of recurrent left lower extremity dvt and pe while therapeutic on coumadin.The patient also has a history of left knee surgery, hammertoe repair, sleep apnea, depression, arthritis, renal stones, diabetes mellitus, gastroesophageal reflux disease, pulmonary hypertension and occasional shortness of breath.During ivc filter implantation via right femoral vein, the filter was positioned and deployed at a level below the renal veins without any complications.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, deep vein thrombosis (dvt), and pulmonary embolism (pe), directly and proximately causing cardiac arrest and death.Per the patient profile form (ppf), sometime post implantation of the ivc filter, the patient suffered blood clots, clotting, and/or occlusion of the ivc, dvt, persistent lower extremity edema, chest pain, shortness of breath with exertion, and anxiety and depression.Neither the autopsy report nor death certificate are available at this time.The filter in unavailable for analysis.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.Blood clots, clotting, pulmonary emboli and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, edema, chest pain and shortness of breath do not represent a device malfunction and may be related to underlying patient related issues.Cardiac arrest (death) is a known potential event associated to the use of the trapease device.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, blood clots, deep vein thrombosis (dvt), and pulmonary embolism (pe), directly and proximately causing cardiac arrest and death.As a direct and proximate result of these filter malfunctions, the patient suffered fatal injuries, damages, and untimely death.The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter because of a history of recurrent left lower extremity dvt and pe while therapeutic on coumadin.The patient also has a history of left knee surgery, hammertoe repair, sleep apnea, depression, arthritis, renal stones, diabetes mellitus, gastroesophageal reflux disease, pulmonary hypertension and occasional shortness of breath.During ivc filter implantation via right femoral vein, the filter was positioned and deployed at a level below the renal veins without any complications.According to the information received in the patient profile form (ppf), sometime post implantation of the ivc filter, the patient suffered blood clots, clotting, and/or occlusion of the ivc, dvt, persistent lower extremity edema, chest pain, shortness of breath with exertion, feelings of hopelessness, doom, and helplessness in not being able to perform normal duties.Neither the autopsy report nor death certificate are available at this time.According to the discovery form, the patient received the ivc filter for deep vein thrombosis (dvt) and pulmonary embolism (pe).Medical conditions and treatments alleged to be attributable to the implanted ivc filter include: dvt, blood clots, lower extremity pain, edema, dyspnea, for which oxygen was prescribed, pulmonary embolism and death.Lovenox, warfarin and tramadol were also prescribed for the patient.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of left knee surgery, hammer toe repair, sleep apnea, depression, arthritis, renal stones, diabetes mellitus, gastroesophageal reflux disease, pulmonary hypertension and occasional shortness of breath.The indication for the filter placement was reported to be because of recurrent left lower extremity deep vein thrombosis (dvt) and pulmonary embolism (pe) despite therapeutic coumadin.The filter was implanted via the right femoral vein and deployed in an infrarenal location without complication.At some point after the filter implantation, the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava (ivc), dvt, pe, persistent lower extremity pain and edema, chest pain, shortness of breath with exertion, feelings of hopelessness and doom and helplessness, cardiac arrest and death.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 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.Recurrent pe is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported lower extremity pain, cardiac arrest, edema, chest pain, shortness of breath experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.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, mental anguish, fear, 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.

• 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: 7207307
• MDR Text Key: 97805170
• Report Number: 1016427-2018-01035
• 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: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15267079
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK,; UNKNOWN GUIDEWIRE.
• Patient Outcome(s): Death
• Patient Age: 62 YR