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

Model Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Occlusion (1984); Internal Organ Perforation (1987); Perforation (2001); Perforation of Vessels (2135)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter had tilted and was associated with perforation.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (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.Without images or procedural films for review, the reported filter tilt and perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.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.

Event Description

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, physical and emotional damages from tilt and perforation of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, distress and other damages.

Event Description

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, physical and emotional damages from tilt and perforation of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, distress and other damages.According to the medical records provided, the inferior vena cava (ivc) filter was placed as the patient developed deep vein thrombosis (dvt) following cervical fusion surgery for cervical spondylosis.Approximately ten years and ten months post implantation, the patient was evaluated and admitted to the hospital for pain and acute coronary syndrome.(acs).At the time of admission, the medical history included a recent removal of benign colonic polyps; flutter/atrial fibrillation status post ablation and biventricular pacemaker placement; bioprosthetic aortic valve placement.The patient was on chronic coumadin anticoagulation and developed provoked dvt and bilateral pulmonary embolus (pe) following cervical fusion surgery status post ivc filter.The medical history also included type 2 diabetes mellitus; hyperlipidemia; asthma; diverticulosis; depression; allergic rhinitis; chronic migraines; nonischemic cardiomyopathy; possible restrictive lung disease; cervical spondylosis without myelopathy and insomnia.Approximately thirteen years and nine months after the filter was implanted, the patient underwent an abdominal computed tomography (ct) study for evaluation of the ivc filter.The ivc filter was noted with the tip 3.4cm distal to the renal vein origins.The tip of the ivc filter abuts the anterior medial wall of the inferior vena cava on axial images.There is associated mild left and anterior tilt of the ivc filter measuring 15 degrees medial to lateral and 20 degrees anterior posterior.The ivc filter struts extend to 3mm beyond the inferior vena cava wall.One of the anterior ivc filter struts extends 2 mm into the distal duodenum posteriorly.One of the ivc filter struts abuts the abdominal aorta.Other ct findings included a 4 mm right middle lobe pulmonary nodule; a mildly enlarged heart and there was advanced calcified atherosclerosis of the coronary arteries and enlargement of the main pulmonary artery suggestive of possible pulmonary artery hypertension.Additionally, two large peripherally calcified gallstones in the gallbladder were noted; moderate to severe pancreatic atrophy; moderate to severe calcified atherosclerosis of the abdominal aorta and visualized branch vessels without focal aneurysmal dilatation.The abdominal aorta was mildly tortuous suggestive of hypertension.Degenerative change of the lumbar spine and mild left-sided curvature of the lumbar spine and right-sided curvature of the lower thoracic spine was reported; cholelithiasis; moderate size fat containing ventral hernia at the midline superior to the umbilicus and moderate size fat containing umbilical hernia were also noted.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately ten years and ten months post implantation.The patient reports perforation of filter strut(s) outside the ivc with the filter abutting the abdominal aorta; perforation of filter strut(s) into organs (duodenum); tilting of the ivc filter, blood clots, clotting and or occlusion of the ivc.The patient further asserts to have suffered post implant dvt and anxiety related to the filter becoming dislodged and being afraid that clots would cause a stroke or heart attack.

Manufacturer Narrative

As reported, a patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the indication was deep vein thrombosis (dvt) following cervical fusion surgery for spondylosis.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, physical and emotional damages from tilt and perforation of the filter.Approximately eleven years post implant, the patient had acute coronary syndrome.(acs).At that time, medical history included a recent removal of benign colonic polyps; diabetes, asthma, diverticulosis, depression, non-ischemic cardiomyopathy, flutter/atrial fibrillation status post ablation and biventricular pacemaker placement; bioprosthetic aortic valve placement, dvt and bilateral pulmonary embolus (pe) following cervical fusion surgery with ivc filter implant, allergic rhinitis and insomnia.Approximately fourteen years post implant, a ct scan noted with the tip of the filter was 3.4cm distal to the renal vein origins.The tip of the ivc filter abuts the anterior medial wall of the inferior vena cava on axial images.There is associated mild left and anterior tilt of the ivc filter measuring 15 degrees medial to lateral and 20 degrees anterior posterior.The ivc filter struts extend to 3mm beyond the inferior vena cava wall.One of the anterior ivc filter struts extends 2 mm into the distal duodenum posteriorly.One of the ivc filter struts abuts the abdominal aorta.Other ct findings included a 4 mm right middle lobe pulmonary nodule; a mildly enlarged heart and there was advanced calcified atherosclerosis of the coronary arteries and enlargement of the main pulmonary artery suggestive of possible pulmonary artery hypertension.Additionally, two large peripherally calcified gallstones in the gallbladder were noted; moderate to severe pancreatic atrophy; moderate to severe calcified atherosclerosis of the abdominal aorta and visualized branch vessels without focal aneurysmal dilatation.The abdominal aorta was mildly tortuous suggestive of hypertension.Degenerative change of the lumbar spine and mild left-sided curvature of the lumbar spine and right-sided curvature of the lower thoracic spine was reported; cholelithiasis; moderate size fat containing ventral hernia at the midline superior to the umbilicus and moderate size fat containing umbilical hernia were also noted.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the ivc with the filter abutting the abdominal aorta; perforation of filter strut(s) into organs (duodenum); tilting of the ivc filter, blood clots, clotting and or occlusion of the ivc.The patient further reports post implant dvt and anxiety.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.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 and surrounding structure perforation from ivc 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, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Post procedural pulmonary embolism is a known potential event associated with the filter device, patent specific issues, specifically the underlying causes of thrombus formation, may contribute to these events.Anxiety and pain 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: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9530012
• MDR Text Key: 188346114
• Report Number: 1016427-2019-03707
• Device Sequence Number: 1
• Product Code: DTK
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2007
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1204333
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR