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

Model Number 466P306AU

Device Problems Fracture (1260); Material Perforation (2205); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation (2001); Perforation of Vessels (2135)

Event Date 11/08/2018

Event Type  Injury  

Manufacturer Narrative

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 perforation of filter strut(s) outside the inferior vena cava (ivc).The indication for the filter implant has not been provided and there is currently no additional information available for review.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 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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without post implant images available for review the reported perforation outside the ivc could not be confirmed or further clarified.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.

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, perforation of filter strut(s) outside the inferior vena cava (ivc).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 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, perforation of filter strut(s) outside the inferior vena cava (ivc).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 and other damages.As per the surgical case record, the proposed procedure was entered as ¿p greenfield filter¿ and the actual procedure as ¿greenfield filter left subclavian¿; however, the operative report indicates a trapease filter placement.Per the operative report, the patient underwent a trapease inferior vena cava (ivc) filter placement after presenting with a recurrent deep venous thrombosis (dvt) on coumadin therapy, and had been undergoing evaluation by oncology for hypercoagulable state since having difficult times maintaining appropriately in the therapeutic range of coumadin.The left subclavian vein was cannulated.Using fluoroscopy an inferior vena cava venogram was performed.The inferior vena cava venography noted a 14mm vena cava that did not appear to have evidence of clotting within, and it did appear to be below the renal veins at the site of deployment at the l2-l3 region.The filter was deployed appropriately in the l2-l3 region.Approximately thirteen years and seven months after the filter was implanted, an abdominal computed tomography (ct) scan was indicated for an unspecified injury of the inferior vena cava and to evaluate ivc filter placement.The ct findings revealed the presence of an inferior vena cava filter placed in the inferior vena cava below the level of the renal arteries.The filter was seen oriented upright and parallel to the long axis of the ivc.Virtually all the struts of the filter extruded through the wall of the inferior vena cava.Other incidental findings included multiple splenic fragments presumably related to prior trauma of the spleen and a fat-containing midline abdominal wall hernia.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately thirteen years and seven months post implantation.The patient reports perforation of filter strut(s) outside the ivc.The patient further asserts to have suffered abdominal and back pain post implant, heavy legs, bilateral swelling of the legs, light headedness, dizziness, shortness of breath and further experienced anxiety and fear related to the filter.According to the information received in the amended patient profile form (ppf), the patient additionally reports fracture of the ivc filter, perforation into organs, tilting, embedment and partial collapse of the ivc filter.Approximately one year after the ct scan was completed, the reformatted images of the ct scan were submitted for review.The report findings noted an infrarenal ivc filter perforating through the ivc with multiple struts extending extraluminal as well as fractured struts.The superior end of the cordis trapease ivc filter is at the mid l2 vertebral body.The ivc filter is tilted anteriorly and laterally at the superior end and is embedded within the ivc wall.The ivc filter is tilted anteriorly at the inferior end and it contacts the ivc wall.All the struts of the ivc filter perforate the ivc up to 9mm.One anterior strut perforates the ivc wall 8mm and contacts the bowel.Two medial struts perforate the ivc wall both 6mm and contact the right iliac artery.Two posterior struts perforate the ivc wall both 7mm and reside within the soft tissues and one lateral strut perforates the ivc wall 9mm and contacts the right kidney.The report also noted that the function of this ivc filter is permanent; and therefore, cannot be removed by a percutaneous approach.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.The patient is reported to have presented with recurrent deep vein thrombosis (dvt) despite anticoagulation therapy.The patient had been undergoing evaluation for the hypercoagulable state prior to an oncology evaluation.The filter was implanted via the left subclavian vein and placed at the level l2-l3 in an infrarenal position.Approximately thirteen years and seven months after the filter implantation, the patient underwent a computerized tomography (ct) scan for evaluation of an unspecified injury to the inferior vena cava (ivc) and to evaluate the filter.The ct scan revealed a filter in an infrarenal position.The filter was noted to be upright and oriented parallel to the long axis of the ivc.Virtually all the struts of the filter extended through the wall of the ivc.Approximately one year later, the patient underwent a repeat ct scan that revealed an infrarenal filter with its¿ superior aspect at the level of the mid-l2 vertebral body.The superior aspect tilted anteriorly and laterally and was embedded within the ivc wall.The inferior aspect of the filter was tilted anteriorly and was in contact with the ivc wall.The anterior strut perforated the ivc wall by 8mm and was in contact with the bowel.Two medial struts perforated the ivc wall by 6mm and was in contact with the right iliac artery.Two posterior struts perforated the ivc by 7mm and were withing the soft tissues and with partial collapse of the filter.The lateral strut perforated the ivc wall by 9mm and was in contact with the right kidney.The report also noted that the trapease vena cava filter was intended to be permanent; and was therefore irretrievable my percutaneous approach.The patient further reported having experienced abdominal and back pain, leg heaviness, bilateral leg swelling, lightheadedness, dizziness, shortness of breath, anxiety and fear associated with the filter.The product was not returned for analysis.The device history record (dhr) review could not be completed.The trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the 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, fracture, perforation events and device embedment 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.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.It is unknown if the tilt contributed to the reported ivc and organ/tissue perforations.A review of the 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.The predominant concern for embedding within 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.The trapease vena cava filter is designed for permanent implantation.Endothelialization has been shown to occur in as short a period as twelve days.Due to the nature of the complaint, the reported pain, leg swelling, lightheadedness, dizziness and shortness of breath experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.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, but not limited to, nervousness, mental anguish, fear, unease and worry.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.

• 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: 9630443
• MDR Text Key: 186314974
• Report Number: 1016427-2020-03756
• 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: 02/18/2020

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 Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 01/26/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR