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

Model Number 466P306X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Perforation of Vessels (2135); Stenosis (2263); Vascular System (Circulation), Impaired (2572)

Event Date 05/03/2019

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, several struts of the filter appear to perforate the wall of the ivc, ivc stenosis and occlusion of the ivc.The filter remains implanted; thus, unavailable for analysis.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.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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.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.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, several struts of the filter appear to perforate the wall of the inferior vena cava, ivc stenosis and occlusion of the ivc.As a direct and proximate result, 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of gall bladder surgery, symptomatic deep vein thrombosis (right lower extremity), profound anemia secondary to bleeding, lower extremity swelling for months with increased right side discomfort, venous thrombosis in the distal right lower extremity, she quit smoking three years prior to index procedure and dyspnea with exertion.It was noted that swelling in the past resolved with recumbency but recently had not.She also complained of chest pain of two types, sharp/stabbing and the other was an ache.The patient had a recent history of abdominal pain, nausea, vomiting, neck pain, cough and low-grade fever.The indication for filter placement was profound anemia secondary to bleeding with deep vein thrombosis, pneumonia and need for blood transfusion.A venocavogram was performed that revealed no thrombus with in the inferior vena cava (ivc), ivc diameter and location of the renal veins the filter was deployed via the patient's right common femoral vein.The filter was placed in a position inferior to the renal veins.The patient tolerated the procedure well.The results of computed tomography (ct) scans done approximately nine years and four months after the index procedure revealed there was a metallic inferior vena cava filter present in the vena cava located at the level of the renal vein confluences.The filter was positioned fairly symmetrically in the vena cava, but extends towards the lower portion of the intrahepatic portion of the inferior vena cava.On the axial views, some of the struts appear to extend beyond the wall of the vena cava but without perforation.This appearance was symmetric and could be simply stretching the vena cava.The vena cava below the level of the stent is severely stenotic and patency was difficult to assess, particularly given its very small size.There are multiple varicose veins seen within the abdominal wall.A vena caval occlusion is highly suspected.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava (ivc), tilt, blood clots, clotting and or occlusion of the ivc.Additionally the patient experienced pain and anxiety.The patient became aware of the reported events approximately nine years and four months after the index procedure.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of gall bladder surgery and previous smoking with exertional dyspnea.In addition, the patient is reported to have had lower extremity swelling over the previous months with increased right-sided pain.The patient presented with chest pain and a recent history of abdominal pain, nausea, vomiting, neck pain, cough and low-grade fever.The indication for the filter placement was reported to be profound anemia secondary to bleeding with dvt and pneumonia and was initially treated with blood transfusion.The filter was implanted via the right common femoral vein and placed in an infrarenal position.The patient is reported to have tolerated the procedure well without difficulty.Approximately nine years and four months after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed a filter at the level of the renal vein confluences.The filter was positioned fairly symmetrically in the ivc but extended toward the lower portion of the intrahepatic portion of the inferior vena cava (ivc).The ct scan report also noted that some of the filter struts appeared to extend beyond the wall of the ivc without perforation; but that this could be attributed to simple stretching of the very small ivc.The report further noted that the vena cava below the level of the filter was severely stenotic and that the patency was difficult to assess.There were also collateral venous channels in the anterior abdominal wall and a caval occlusion was highly suspected.The patient reported that the filter had tilted with filter strut(s) outside the ivc and was associated with blood clots, clotting and/or ivc occlusion.The patient further reported having experienced pain, mental anguish and anxiety 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 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 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.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 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.Collateral circulation is the circulation of blood established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.It does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter.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 CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10492189
• MDR Text Key: 205724139
• Report Number: 1016427-2020-04346
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1008321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 GLIDE WIRE; UNKNOWN CANNULATED NEEDLE; UNKNOWN DILATOR; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 56 YR
• Patient Weight: 85