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

Model Number 466P306AU

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

Per the patient profile form (ppf), the patient reports that after trapease implantation ivc occlusion, numbness in the left foot, back pain and anxiety related to the filter occurred.Per the medical records, history includes diabetes, hypertension and chronic anemia.The indication for filter placement was right lower extremity swelling with deep vein thrombosis (dvt) and multiple bilateral pulmonary emboli (pe).A venocavogram located the renal veins and assessed the caliber of the ivc.The filter was successfully deployed in an infrarenal position.There were no reports of complications.Approximately twelve years and two months after implant, a ct scan reported the ivc is collapsed and occluded below the level of the ivc filter.There are bilateral collateral vessels which drain into the venous system above the level of the ivc.Incidental findings included a fatty liver, multiple areas of cortical thinning suggesting changes related to previous reflux or infection, small fat containing umbilical hernia and mild degenerative disc disease of the spine.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Collateral circulation maybe related to the reported occlusion of the filter/ivc and is a known potential event following ivc filter implantation.Anxiety, numbness 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.

Event Description

Per the medical records, the patient was reported to have a history of diabetes, hypertension and chronic anemia, and prior to the index procedure was admitted to the hospital for right lower extremity swelling.Evaluation showed that the patient had a right lower extremity deep vein thrombosis (dvt), and a computerized tomography (ct) pulmonary angiogram, revealed multiple bilateral pulmonary emboli (pe).The patient was started on anticoagulant therapy and ultimately consented to an inferior vena cava (ivc) filter given the risk of hemorrhage.The right groin was prepared and draped in usual, strict aseptic fashion and utilizing ultrasound guidance, the femoral vein was accessed with a micropuncture needle.A catheter was then advanced to the mid ivc and contrast was injected during digital subtraction filming of the abdomen in the frontal projection.The ivc filter delivery sheath was placed with its tip at the level of the entry of the renal veins.The ivc filter was deployed in an ideal position with its apex at the level of the entry the renal veins.An inferior venacavogram was performed at the conclusion of the procedure to confirm the position of the filter, demonstrating a widely patent inferior vena cava with no caval thrombi.The patient tolerated the procedure well.There were no reported complications.Approximately twelve years and two months after the filter was implanted, the patient underwent an abdominal computerized tomography (ct) scan indicated for filter evaluation.The scan reported an intrarenal inferior vena cava filter.The ivc is collapsed and appears to be occluded below the level of the ivc filter.There are bilateral collateral vessels which drain into the venous system above the level of the ivc.Incidental findings included a fatty liver, multiple areas of cortical thinning suggesting changes related to previous reflux or infection, small fat containing umbilical hernia and mild degenerative disc disease of the spine.According to the information received in the patient profile form (ppf), the patient reports occlusion, becoming aware of this event approximately twelve years and two months after the filter implantation, and further experienced numbness in the left foot, back pain and anxiety related to the filter.

Manufacturer Narrative

As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned including ivc occlusion and the resultant symptoms.Per the medical records, the indication was right leg dvt (deep vein thrombosis) and multiple pulmonary emboli (pe); history includes diabetes, hypertension and chronic anemia.A venocavogram located the renal veins and assessed the caliber of the ivc.The filter was successfully deployed in an infrarenal position.There were no reports of complications.Approximately twelve years and two months after implant, a ct scan reported the ivc is collapsed and appears to be occluded below the level of the ivc filter, with bilateral collateral vessels.Incidental findings included a fatty liver, cortical thinning related to previous reflux or infection, small umbilical hernia and mild degenerative disc disease of the spine.Per the patient profile form (ppf), the patient reports occlusion, numbness in the left foot, back pain and anxiety related to 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 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Collateral circulation maybe related to the reported occlusion of the filter/ivc and is a known potential event following ivc filter implantation.Anxiety, numbness 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.

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 occlusion 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, suffering, loss of enjoyment of life, distress and other damages.Per the medical records, the patient was reported to have a history of diabetes, hypertension and chronic anemia, and prior to the index procedure was admitted to the hospital for right lower extremity swelling.Evaluation showed that the patient had a right lower extremity deep vein thrombosis (dvt), and a computerized tomography (ct) pulmonary angiogram, revealed multiple bilateral pulmonary emboli (pe).The patient was started on anticoagulant therapy and ultimately consented to an inferior vena cava (ivc) filter given the risk of hemorrhage.The right groin was prepared and draped in usual, strict aseptic fashion and utilizing ultrasound guidance, the femoral vein was accessed with a micropuncture needle.A catheter was then advanced to the mid ivc and contrast was injected during digital subtraction filming of the abdomen in the frontal projection.The ivc filter delivery sheath was placed with its tip at the level of the entry of the renal veins.The ivc filter was deployed in an ideal position with its apex at the level of the entry the renal veins.An inferior venacavogram was performed at the conclusion of the procedure to confirm the position of the filter, demonstrating a widely patent inferior vena cava with no caval thrombi.The patient tolerated the procedure well.There were no reported complications.Approximately twelve years and two months after the filter was implanted, the patient underwent an abdominal computerized tomography (ct) scan indicated for filter evaluation.The scan reported an intrarenal inferior vena cava filter.The ivc is collapsed and appears to be occluded below the level of the ivc filter.There are bilateral collateral vessels which drain into the venous system above the level of the ivc.Incidental findings included a fatty liver, multiple areas of cortical thinning suggesting changes related to previous reflux or infection, small fat containing umbilical hernia and mild degenerative disc disease of the spine.According to the information received in the patient profile form (ppf), the patient reports occlusion, becoming aware of this event approximately twelve years and two months after the filter implantation, and further experienced numbness in the left foot, back pain and anxiety related to the filter.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 11347745
• MDR Text Key: 232516843
• Report Number: 1016427-2021-04774
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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
• Device Lot Number: R0408512
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK 0.035 NEWTON GUIDEWIRE; COOK 5F PIGTAIL; UNK MICROPUNCTURE NEEDLE; COOK 0.035 NEWTON GUIDEWIRE; COOK 5F PIGTAIL; UNK MICROPUNCTURE NEEDLE
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR
• Patient Weight: 88