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

Model Number 466P306X

Device Problem Difficult to Remove (1528)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Swelling (2091); Stenosis (2263)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, 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, filter stenosis.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, pain and suffering, and other damages.According to the information received in the patient profile from (ppf), the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting and/or occlusion of the ivc, stenosis, and device unable to be retrieved.An attempted but unsuccessful percutaneous removal procedure was performed at an unknown date.The patient reports swollen legs and difficulty walking, which resulted in the patient being disabled.According to the additional information received per the medical records, the patient has a history of deep vein thrombosis and recurrent pulmonary thromboembolism and supermorbid obesity.During the implant procedure, the filter was placed via the right femoral vein.A ct scan of the patient was taken six years and three months post implantation.A stent device over the anterior aspect of the ivc was noted and abuts the superior portion of the ivc filter.The filter was noted to not be significantly tilted.

Manufacturer Narrative

As reported, a patient underwent placement of a trapease vena cava filter.The information provided indicated that post implant there was filter stenosis and the patient experienced blood clots, clotting and/or occlusion of the ivc.The information also indicated that the device was not able to be retrieved and there was an unsuccessful percutaneous retrieval attempt on an unknown date.The patient also reports swollen legs and difficulty walking, which resulted in the patient being disabled.According to the medical records, the patient had a history of deep vein thrombosis and recurrent pulmonary thromboembolism and supermorbid obesity.During the implant procedure, the filter was placed via the right femoral vein.A computed tomography (ct) scan of the patient was taken six years and three months post implant.The report of the ct scan noted a stent device over the anterior aspect of the ivc was noted and abuts the superior portion of the ivc filter.Of note the patient had a stent placed one year prior to the ct scan.The filter was noted to not be significantly tilted.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, stenosis, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Leg swelling and difficulty walking do not represent a device malfunction and may be related to underlying patient specific issues, specifically a prior history of obesity and deep vein thrombosis.That are occurring at any given time.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: 8615430
• MDR Text Key: 145230724
• Report Number: 1016427-2019-02849
• 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: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Device Lot Number: 15553260
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR