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 Pulmonary Embolism (1498); Embolism (1829); Embolus (1830); Occlusion (1984); Peripheral Vascular Disease (2002); Swelling (2091); Thrombosis (2100); Stenosis (2263); Vascular System (Circulation), Impaired (2572)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).As reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to acute venous embolism, thrombosis of the deep vessels, and venous insufficiency.As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages.Additional information received via plaintiff profile form (ppf) states that the patient has suffered from blood clots, clotting, and/or occlusion of the ivc, peripheral vascular disease of the leg, and pulmonary embolism post ivc filter implant.The patient is forced to live with the possibility that complications can happen to the patient at any moment which has lead the patient to severe fear, stress, anxiety and loss of enjoyment of life.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 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.Venous insufficiency is describing the inability of valves in the veins to adequately advance blood flow.This decrease in blood flow may possibly lead to the formation of thrombus in the venous system.Venous embolism, clotting (such as noted with deep vein thrombosis) and occlusion within the ivc does not represent a device malfunction.An occlusion within the vena cava or lower extremities may impede perfusion and cause venous insufficiency leading to possible swelling and pain of the lower extremities clinical factors that may have influenced the events described include patient, pharmacological, lesion characteristics or other comorbidities.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 nervousness, unease and worry.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.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.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 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 defendants¿ trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to acute venous embolism, thrombosis of the deep vessels, and venous insufficiency.As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages.Additional information received via plaintiff profile form on 05/03/2018: the patient has suffered from blood clots, clotting, and/or occlusion of the ivc.Peripheral vascular disease of the leg, pulmonary embolism post ivc filter implant.The patient is forced to live with the possibility that complications can happen to the patient at any moment which has lead the patient to severe fear, stress, anxiety and loss of enjoyment of life.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.According to the information received in the patient short form, the patient has ivc stenosis, leg swelling, and collateral veins.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following other relevant history, pma/510k, and if follow-up, what type have been updated accordingly.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 acute venous embolism, thrombosis of the deep vessels, venous insufficiency, inferior vena cava stenosis, leg swelling, collateral veins, peripheral vascular disease of the leg, pulmonary embolism (pe).The patient is also reported to have fear, stress, anxiety and loss of enjoyment of life.The patient¿s medical history consists of hypercoagulable disorder, coronary artery disease (cad), peripheral vascular disease, herniated disc, bilateral inguinal hernia repair, varicose veins, bilateral pe and recurrent deep vein thrombosis (dvt).The patient was also on coumadin since the diagnosis of the disorder.The coumadin was discontinued prior to inguinal hernia repair and was re-started after the procedure.Prior to the filter implantation, the patient had developed chest pressure and shortness of breath.The patient was found to have bilateral pe and dvt in the left lower extremity.During the filter placement procedure, the filter was deployed in the ivc.The patient was sent to recovery in satisfactory completion.Approximately four years and three months post implantation the patient experienced blood clots, clotting, occlusion of the inferior vena cava (ivc), peripheral vascular disease of the leg and pulmonary embolism (pe).There is currently no additional information available for review.The product was not returned for analysis.A review of the device history record (dhr) associated with lot 15426498 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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.A device malfunction has not been reported at this time.Venous insufficiency is describing the inability of valves in the veins to adequately advance blood flow.This decrease in blood flow may possibly lead to the formation of thrombus in the venous system.Venous embolism, clotting (such as noted with deep vein thrombosis) and occlusion within the ivc does not represent a device malfunction.An occlusion within the vena cava or lower extremities may impede perfusion and cause venous insufficiency leading to possible swelling and pain of the lower extremities.Collateral circulation is the circulation of blood established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.Clinical factors that may have influenced the events described include patient, pharmacological, lesion characteristics or other comorbidities.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 nervousness, unease and worry.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Review of the information provided suggests that patient factors, specifically, hypercoagulable disorder, peripheral vascular disease and varicose veins may have contributed to the reported events 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 manufacturing process of the device; therefore no corrective action will be taken.

• 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: 7548602
• MDR Text Key: 109373677
• Report Number: 1016427-2018-01491
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15426496
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/22/2018; 06/26/2018
• Supplement Dates FDA Received: 06/21/2018; 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR