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

Catalog Number 466P306AU

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

Patient Problems Occlusion (1984); Respiratory Distress (2045); Thrombosis (2100)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

The sterile lot number was not available, device history record review could not be performed.The product remains implanted and is thus not available for analysis.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to breathing problems requiring constant oxygen caused by complications associated with the inferior vena cava (ivc) filter.As a direct and proximate result of these malfunctions, the patient suffered life­ threatening injuries, 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.

Manufacturer Narrative

As reported, the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to breathing problems requiring constant oxygen caused by complications associated with the inferior vena cava (ivc) filter.As a direct and proximate result of these malfunctions, the patient suffered life­ threatening injuries, 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.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 (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.The legal brief does not mention a malfunction of the filter.Without medical records available for review, it is not possible to draw a clinical conclusion between the respiratory difficulties experienced by the patient and the inferior vena cava filter.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

The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter due to their history of pulmonary embolism and deep vein thrombosis.The patient also has a history of abnormal nuclear stress test with reversible ischemia in the inferior wall and apex, carotid artery disease, left carotid endarterectomy, shortness of breath, obesity, coronary artery disease, hypoxia, hyponatremia, hyperlipidemia, hypertension, chest pain, coronary artery bypass grafting (cabg) times two with endoscopic vein harvesting, bilateral pleural effusions, hyperglycemia, multi-infarct cerebral vascular disease, pneumonia, severe degenerative arthritis of the knees, left shoulder surgery, left knee arthroscopic surgery, former cigarette and cigar smoker, and congestive heart failure.During placement of the ivc filter via the right common femoral vein, a venogram was performed followed by passing of a trapease filter which was positioned below the renal veins.The filter was positioned adequately.The patient left the operating room in excellent condition.One day later, a 2d echocardiograph was done because of shortness of breath and showed normal findings except for mild tricuspid valve regurgitation and mitral valve regurgitation.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events approximately on or about ten years and four months.The patient reports to suffer from blood clots, clotting, and/or occlusion of the ivc, and that the device is unable to be retrieved.However, no known filter retrieval attempts have been made.The patient also states to suffer from mental anguish due to the filter not being able to be removed since it is ¿plugged total.¿ the patient states to not being able to breath and to need a heart procedure to be performed but since the ivc filter is ¿plugged¿ it could not be done.It was reported that a patient underwent placement of a trapease inferior vena cava (ivc) filter.The information provided indicated that the filter malfunctioned and caused injury to the patient, including, but not limited to breathing problems requiring constant oxygen.The patient is also reported to have experienced blood clots, clotting, and/or occlusion of the ivc, and that the device is unable to be retrieved.However, no known filter retrieval attempts have been made.The patient also states to suffer from mental anguish due to the filter not being able to be removed since it is ¿plugged total.¿ the patient states to not being able to breath and to need a heart procedure to be performed but since the ivc filter is ¿plugged¿ it could not be done.The patient¿s history was significant for abnormal nuclear stress test with reversible ischemia in the inferior wall and apex, carotid artery disease, left carotid endarterectomy, shortness of breath, obesity, coronary artery disease, hypoxia, hyponatremia, hyperlipidemia, hypertension, chest pain, coronary artery bypass grafting (cabg) times two, bilateral pleural effusions, hyperglycemia, multi-infarct cerebral vascular disease, pneumonia, severe degenerative arthritis of the knees, left shoulder surgery, left knee arthroscopic surgery, former cigarette and cigar smoker, and congestive heart failure.The indication for the filter placement was pulmonary embolism (pe) in the main pulmonary artery and extensive bilateral deep vein thrombosis (dvt).The patient presented with shortness of breath and fatigue approximately two weeks after undergoing coronary artery bypass graft surgery.The filter was placed via the right common femoral vein and positioned below the level of the renal veins.The filter was positioned adequately, and the patient left the operating room in excellent condition.One day later, a 2d echocardiograph was performed because of shortness of breath and showed normal findings except for mild tricuspid valve regurgitation and mitral valve regurgitation.There is currently no additional information available for review.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 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.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could not be confirmed or further clarified.Breathing problems and anxiety do not represent a device malfunction and may be related to underlying patient specific issues and/or the patient¿s medical history.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Given the limited information currently 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: 7549660
• MDR Text Key: 109426011
• Report Number: 1016427-2018-01496
• 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
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0107449
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 77 YR
• Patient Weight: 135