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

Catalog Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100)

Event Date 02/15/2016

Event Type  Injury  

Manufacturer Narrative

As reported, the 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: caval thrombosis, deep vein thrombosis (dvt) and tilt of the ivc filter.As a direct and proximate result of these malfunctions the patient suffered life-threatening injuries and 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.The devices were not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The inferior 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 that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Deep vein thrombosis (dvt) occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.The presence of these clots do not represent a device malfunction.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.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 reported filter tilt is unknown.Patient, technique or procedural factors may have contributed to the reported tilt.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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 brief, the 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: caval thrombosis, deep vein thrombosis (dvt) and tilt of the ivc filter.As a direct and proximate result of these malfunctions the patient suffered life-threatening injuries and 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 month before the index procedure, the patient had a bilateral pulmonary emboli and was treated with anticoagulation therapy.The therapy needed to be discontinued due to life-threatening gastrointestinal bleeding.  the filter was deployed via the right femoral vein using ultrasound guidance.The filter was placed so that its apex was 1.5 cm below the renal veins.The patient tolerated the procedure well and there were no immediate complications.The filter was deployed in a good position.The patient profile form (ppf) states that a computed tomography (ct) scan was performed for evaluation of the filter.Clotting was noted, thrombosis and deep vein thrombosis were further discovered to have extended through the filter.Upon removal, the filter was found to have tilted and embedded.02/15/2016- forty days after the index procedure, the patient became aware of the following events: blood clots, clotting and/or occlusion of the inferior vena cava.The medical records state that forty eight days after the index procedure, the patient underwent a vena caval and bi-iliac mechanical thromboeembolectomy and the filter was removed.During the removal procedure it was noted that there was some residual thrombus in the cephalic apex of the filter.After removal of the filter an venogram showed no caval injury or extravasation, but there was new thrombus in the inferior vena cava at the iliac confluence below the former filter.A mechanical thromboeembolectomy was performed.Another venogram was performed showing no iliac or inferior vena cava thrombus.Additional information received per the patient profile form (ppf) states that the patient experienced caval thrombosis, deep vein thrombosis, tilting of the filter, filter embedded in wall of the inferior vena cava, blood clots, clotting, and/or occlusion of the inferior vena cava, emotional distress, mental anguish, anxiety and stress.

Manufacturer Narrative

As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the month before the index procedure, the patient had a bilateral pulmonary embolus and was treated with anticoagulation therapy.The therapy needed to be discontinued due to life-threating gastrointestinal bleeding.The filter was placed so that its apex was 1.5 cm below the renal veins.The patient tolerated the procedure well and there were no immediate complications.The filter was deployed in a good position.The filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to: caval thrombosis, deep vein thrombosis (dvt) and tilt of the ivc filter.Per the patient profile form (ppf), a ct scan was performed for evaluation of the filter.Clotting was noted, thrombosis and deep vein thrombosis were further discovered to have extended through the filter.Upon removal, the filter was found to have tilted and embedded.Forty days after the index procedure, the patient became aware of the following events: blood clots, clotting and/or occlusion of the inferior vena cava.The medical records state that forty eight days after the index procedure, the patient underwent a vena caval and bi-iliac mechanical thromboeembolectomy and the filter was removed.During the removal procedure it was noted that there was some residual thrombus in the cephalic apex of the filter.After removal of the filter a venogram showed no caval injury or extravasation, but there was new thrombus in the inferior vena cava at the iliac confluence below the former filter.A mechanical thromboeembolectomy was performed.Another venogram was performed showing no iliac or inferior vena cava thrombus.Additional information received per the patient profile form (ppf) states that the patient experienced caval thrombosis, deep vein thrombosis, tilting of the filter, filter embedded in wall of the inferior vena cava, blood clots, clotting, and/or occlusion of the inferior vena cava, emotional distress, mental anguish, anxiety and stress.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.Blood clots, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.Correction section e2: health professional? no section e3: occupation: other, senior counsel, litigation.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8371372
• MDR Text Key: 137232356
• Report Number: 1016427-2019-02558
• Device Sequence Number: 1
• Product Code: DQO
• 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: 05/09/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17335404
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.018 GUIDE WIRE; UNKNOWN 22 GAUGE ECHO NEEDLE; UNKNOWN 5 FRENCH PIGTAIL CATHETER; UNKNOWN MICROPUNCTURE DILATOR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 73 YR