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

Model Number 466P306X

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

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Pain (1994); Thrombosis (2100); Anxiety (2328)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

The device remains implanted and is not available for inspection.Complaint conclusion-as reported by the legal department, the patient was implanted with a cordis trapease inferior vena cava filter (ivcf).Subsequently, the patient suffered several deep vein thromboses.As a result of the malfunction, the patient has suffered life-threatening injuries and damages and required extensive medical care and treatment.Plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.The device has not been returned for analysis.Additionally, a device history record review could not be conducted as a sterile lot number was not received.Without medical records and films for review, the reported deep vein thrombosis (dvt) could not be confirmed.The cordis trapease filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava in the following situations: pulmonary thromboembolism when anticoagulants are contraindicated, failure of anticoagulant therapy for thromboembolic disease, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced, chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.Blood clots, clotting, and dvt may be associated with immobility, medications, high blood pressure, high cholesterol, smoking, surgery, and family history.Blood clots, once formed, can travel to other parts of the body causing harm.In addition, a blood clot in an artery that supplies blood to the heart or brain may result in heart attack, stroke, or transient ischemic attack (tia).With the information available, the timing and clinical cause for the reported dvt could not be conclusively determined.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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 department, the patient was implanted with a cordis trapease inferior vena cava filter (ivcf).Subsequently, the patient suffered several deep vein thromboses.As a result of the malfunction, the patient has suffered life-threatening injuries and damages and required extensive medical care and treatment.Plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.

Manufacturer Narrative

Additional information received indicates that on or approximately four years and eight months post-implantation the patient suffered blood clots, clotting and/or occlusion of the ivc.The patient is also reported to be anxious and have suffered multiple dvts and pulmonary embolisms (pe).Originally, the patient tolerated the index procedure well and left recovery in stable condition.A review of lot (15401657) revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

It was reported that a patient had a trapease inferior vena cava filter (ivc) implanted.The indication for the implant was thrombosis in the common femoral vein, the superficial femoral vein and the popliteal vein.It was reported that the patient has subsequently suffered several deep vein thromboses (dvt).As a result of the malfunction, the patient has suffered life-threatening injuries and damages and required extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.According to the patient profile form approximately four years and eight months post-implantation the patient suffered blood clots, clotting and/or occlusion of the ivc.The patient is also reported to be anxious and have suffered multiple dvts and pulmonary embolisms (pe).It was reported that the patient tolerated the index procedure well and left recovery in stable condition.There is no other information currently available.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 event.The trapease 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.Pulmonary embolism and filter occlusion are known long term complications associated with filter implant and are listed as such in the instructions for use (ifu).Clotting, deep vein thrombosis, pulmonary emboli and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and a device malfunction could be confirmed.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami lakes FL ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; juarez chihuahua ; EI
• Manufacturer Contact: karla castro ; 1 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6128029
• MDR Text Key: 60904651
• Report Number: 1016427-2016-00127
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15401657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/26/2016
• Date Manufacturer Received: 12/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 88