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 Vessel Or Plaque, Device Embedded In (1204); Dyspnea (1816); Occlusion (1984); Perforation (2001); Thrombosis (2100); Perforation of Vessels (2135); No Code Available (3191)

Event Date 04/22/2015

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned, including, but not limited to, perforation, and caused injury and damages to the patient.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.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.An 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 briefing mentioned a perforation of the ivc wall.Without procedural films available for review, the reported perforation could not be confirmed.With the information available it is not possible to draw a clinical conclusion to the reported event, and the exact cause could not be determined.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Also, with 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.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, including, but not limited to, perforation, and caused injury and damages to the patient.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.

Manufacturer Narrative

The following additional information received per the medical records indicate that patient underwent placement of the inferior vena cava (ivc) filter due to having a massive pulmonary embolism and having bleeding issues with anticoagulation.During the implantation of the ivc filter via the right femoral vein, the filter was deployed at the superior portion of the l2 without difficulty.A completion venogram was performed and the filter was noted to be infrarenal and above the bifurcation.The patient tolerated the procedure well.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events four years and two months post implantation of the ivc filter when the patient underwent a venogram where it was noted to have complete occlusion of the left and right femoral veins, bilateral iliac veins, and ivc inferior to the filter.Two day later, the patient underwent thrombotic treatment and upon discharge from the hospital was diagnosed with post-thrombotic syndrome.The patient also reports that to have perforation of filter struts outside the ivc, filter embedded in wall of the ivc, the filter unable to be retrieved, blood clots, clotting, and occlusion of the ivc.However, no known removal attempts of the ivc filter have been noted.The patient also reports to suffer from fatigue, swelling, vascular damage, shortness of breath, dizziness, and pain post implant due to these complications.Additionally, the patient reports to being unable to work, having to be on anticoagulation for life, and having to use a lymphedema pump.As a result, the patient states to also suffer from emotional distress, mental anguish, anxiety, and stress.(b)(4).As reported, the patient underwent placement of the trapease inferior vena cava filter.Per the medical records, the patient underwent placement of the inferior vena cava (ivc) filter due to a massive pulmonary embolism and bleeding issues with anticoagulation.During the implantation of the ivc filter via the right femoral vein, the filter was deployed at the superior portion of the l2 without difficulty.A completion venogram was performed and the filter was noted to be infrarenal and above the bifurcation.The patient tolerated the procedure well.The filter subsequently malfunctioned, including, but not limited to, perforation, and caused injury and damages to the patient.Per the patient profile from (ppf), approximately four years post implantation, a venogram noted complete occlusion of the left and right femoral veins, bilateral iliac veins, and ivc inferior to the filter.Two days after the venogram, the patient underwent thrombotic treatment and was discharged with the diagnosis of post-thrombotic syndrome.The patient also reports perforation of filter struts outside the ivc, filter embedded in wall of the ivc, the filter unable to be retrieved, blood clots, clotting, and occlusion of the ivc.However, no known removal attempts of the ivc filter have been noted.The patient also reports to suffer from fatigue, swelling, vascular damage, shortness of breath, dizziness, anxiety and pain post implant.Additionally, the patient reports having to use a lymphedema pump.The filter remains implanted; thus, 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.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 occur in as short a period as 12 days.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots, clotting, post thrombotic syndrome and occlusive thrombosis within the filter and vasculature do not represent a device malfunction and may be related to the underlying coagulopathy issues that are patient specific.Anxiety, shortness of breath, dizziness, pain, fatigue and swelling 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.

• 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: 7375307
• MDR Text Key: 103654249
• Report Number: 1016427-2018-01292
• 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
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15284550
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER; UNKNOWN GUIDE WIRE; UNKNOWN OBTURATOR
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR