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

Catalog Number 466P306AU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Thrombosis (2100); Stenosis (2263); Vascular System (Circulation), Impaired (2572)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

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 inferior vena cava (ivc) filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to stenosis inferior to the filter, post-implant deep vein thrombosis and post-implant pulmonary embolism.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.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.Blood clots, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Post procedural pulmonary embolism is a known potential event associated with the filter device, patent specific issues, specifically the underlying causes of thrombus formation, may contribute to these events.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.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 stenosis inferior to the filter, post-implant deep vein thrombosis and post-implant pulmonary embolism.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

As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, history includes spinal cord injury, with bilateral lower extremity deep vein thrombosis.The filter was deployed in the infrarenal area of the inferior vena cava.The patient tolerated the procedure well with no evidence of complications.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to stenosis inferior to the filter, post-implant deep vein thrombosis and post-implant pulmonary embolism.A ct scan, done approximately nine years and seven months after the index procedure, indicates that the filter was in place.There was chronic thrombosis/occlusion of the inferior vena cava at the level of the filter with calcified thrombus.The scan also revealed aortic atherosclerosis without evidence of aneurysm or dissection, evidence of old granulomatous disease, borderline enlarged mediastinal hilar lymph nodes, coronary artery calcifications and mild emphysema with peripheral blebs and bulla.A ct scan, done approximately ten years and two months after the index procedure, indicates that the struts appear intact, there is no abnormal tilting, migration or perforation.The inferior vena cava appears stenotic inferior to the filter.Collateral vessels were noted along the anterior abdominal wall.Per the patient profile form (ppf), the patient reports stenosis, blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The patient also experienced venous stasis insufficiency, stasis dermatitis and lipodermatosclerosis.This resulted in the complete loss of skin and multiple seeping ulcers on both lower extremities, these extended from below the ankle to the knee on the left leg and below the ankle to mid-thigh on the right leg.The patient also experienced stress and anxiety.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, collateral circulation and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does 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.

Manufacturer Narrative

After further review of additional information received, section h6: patient code '2572' was used for 'collateral vessels.Section b5: additional information received per the medical records indicate that the patient has a history of spinal cord injury, bilateral lower extremity deep vein thrombosis.The filter was deployed via right common femoral vein.It was placed in the infrarenal area of the inferior vena cava.The patient tolerated the procedure well with no evidence of complications.  the results of computed tomography (ct) scans done approximately nine years and seven months after the index procedure indicate that the filter was in place.There was chronic thrombosis/occlusion of the inferior vena cava at the level of the filter with calcified thrombus.The scan also revealed aortic atherosclerosis without evidence of aneurysm or dissection, evidence of old granulomatous disease, borderline enlarged mediastinal hilar lymph nodes, coronary artery calcifications and mild emphysema with peripheral blebs and bulla.The results of computed tomography (ct) scans done approximately ten years and two months after the index procedure indicate that the struts appear intact, there is no abnormal tilting, migration or perforation.The inferior vena cava appears stenotic inferior to the filter.Collateral vessels were noted along the anterior abdominal wall.Additional information received per the patient profile form (ppf) states that the patient experienced stenosis, blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The patient became aware of the reported events nine years and seven months after the index procedure.The patient also experienced venous stasis insufficiency, stasis dermatitis and lipodermatosclerosis.This resulted in the complete loss of skin and multiple seeping ulcers on both lower extremities, these extended from below the ankle to the knee on the left leg and below the ankle to mid-thigh on the right leg.The patient also experienced stress and anxiety.  additional information is pending and will be submitted within 30 days of receipt.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; EI
• MDR Report Key: 8319879
• MDR Text Key: 135506817
• Report Number: 1016427-2019-02480
• 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,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0107038
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• Patient Sequence Number: 1
• Treatment: UNKNOWN 4 FRENCH PIGTAIL CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR