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

Catalog Number 466P306AU

Device Problems Failure to Align (2522); Unintended Movement (3026)

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Occlusion (1984); Perforation of Vessels (2135); Stenosis (2263)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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 was associated with malposition and stenosis of the inferior vena cava (ivc).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 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 malposition could not be confirmed and the exact cause could not be determined.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.Please note that this is the initial/final report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to malposition of the filter in the inferior vena cava (ivc) that has caused stenosis of the ivc.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

After further review of additional information received the following sections a2, b3, b5, b7,d1, d4,g4, g7, h1,h2,h4 and h6 have been updated accordingly.Section b5:addendum for additional information received: the following additional information received per the patient profile form (ppf) indicates that approximately two years and seven months after implantation, the patient became aware that there was perforation of the filter struts outside of the ivc, the device was tilted, there was also a presence of blood clots, clotting, and or occlusion of the ivc.The patient also states to have stenosis of the ivc and lifelong anticoagulation.After filter placement the patient subsequently developed a pulmonary embolism and sepsis, which required hospitalization and was in a coma for two weeks.The patient is said to have sharp pains on the right side of the body near the abdomen, generalized weakness, dizzy spells, fatigue, chest pain, shortness of breath and coughing.The patient states to experience anxiety for which they are being prescribed anti-anxiety medication.According to the implant records the patient is reported to have a pre-operative diagnosis of a massive pulmonary artery embolus, symptomatic, with large thrombus burden in the right lower extremity deep venous thrombosis.The patient was admitted initially with severe dyspnea and pleuritic chest pain.The patient was found to have a massive pulmonary embolus with bilateral main pulmonary artery large thrombus and peripheral pulmonary artery thrombus, the patient also had a large amount of thrombus in the right lower extremity, it was then decided by the physician to place the inferior vena cava filter.The filter was deployed between the superior plate of l2 and l3.The patient tolerated the procedure very well and was subsequently taken to the recovery room in stable condition.According to the ct records the inferior aspect of the inferior vena cava below the filter appears stenotic.Minimal anterolateral tilt of the superior aspect of the ivc filter.There was no evidence of strut perforation and the filter appears to be intact.As reported, the patient underwent placement of a trapease vena cava filter.The patient was initially admitted with severe dyspnea and pleuritic chest pain.Diagnostic testing revealed a massive bilateral pulmonary embolus (pe) of the main and peripheral pulmonary arteries.The patient was also noted to have a deep vein thrombosis (dvt) with a large amount of thrombus in the right lower extremity.The filter was implanted via the right internal jugular vein and placed between the superior plate of l2 and l3.The patient is reported to have tolerated the procedure well.Approximately two years and seven months after the filter implantation, the patient became aware that the filter had tilted and that the filter struts had perforated outside the inferior vena cava (ivc).The patient also reported that the filter was malpositioned causing stenosis of the ivc, blood clots, clotting and/or occlusion of the ivc.In addition, the patient required lifelong anticoagulation therapy.A computerized tomography (ct) scan revealed that the inferior aspect of the ivc appeared stenotic.There was a minimal anterolateral tilt of the superior aspect of the filter.The filter was in an infrarenal position and appeared to be intact.There was no evidence of strut perforation.At some point after the filter implantation, the patient reported having developed a pe requiring hospitalization.The patient is reported to have been in a coma for two weeks.The patient further reported having experienced sharp right-sided abdominal pain, generalized weakness, dizziness, fatigue, shortness of breath, coughing and anxiety requiring medication associated with the filter.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 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, malposition and ivc 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.Recurrent pe is a known potential complication of filter implantation and is listed in the ifu as such.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Stenosis, blood clots, clotting, embolism, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported pain, shortness of breath, fatigue and dizziness 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.

Manufacturer Narrative

Section h6 was updated to include the analysis of production records.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10294972
• MDR Text Key: 199704674
• Report Number: 1016427-2020-04219
• 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: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17317209
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR