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

Catalog Number 466P306AU

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

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984)

Event Date 05/04/2018

Event Type  Injury  

Manufacturer Narrative

The sterile lot number was not available, product history record review could not be performed.The product remains implanted and is thus not available for analysis.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient had a trapease filter implanted in his inferior vena cava (ivc).The filter has failed to prevent the patient from suffering pulmonary emboli and, on information and belief has caused the formation of thrombus resulting in pulmonary emboli with filter in place.

Manufacturer Narrative

The following sections have been updated accordingly.As reported, the patient had a trapease filter implanted in his inferior vena cava (ivc).The filter has failed to prevent the patient from suffering pulmonary emboli and, on information and belief has caused the formation of thrombus resulting in pulmonary emboli with filter in place.The device was 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 (ivc) 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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported event.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.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.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis and deep vein thrombosis with pulmonary embolism.The filter was deployed via the right common femoral vein.The device was placed between the left renal vein and the bifurcation of the vena cava.The patent tolerated the procedure well.Additional information received per the patient profile form (ppf) states that the patient also experienced occlusion of the inferior vena cava along with reoccurrence of blood clots in feet, legs, thighs and lungs.It was reported that a patient had a trapease filter implanted in the inferior vena cava (ivc).The information provided indicated that the filter has failed to prevent the patient from experiencing a pulmonary embolus and has caused the formation of thrombus resulting in pulmonary emboli with filter in place.The patient is also reported to have experienced occlusion of the inferior vena cava along with reoccurrence of blood clots in feet, legs, thighs and lungs.The indication for the filter implant was deep vein thrombosis (dvt) of the left superficial and the left common femoral vein and pulmonary embolism (pe).The filter was placed via the right common femoral vein and deployed at a location between the left renal vein and the bifurcation of the vena cava.The patient tolerated the procedure well and there were not reported complications.There was no thrombus noted, during placement of the filter, of the right iliac venous system.There is currently no additional information available for review.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 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.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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.The filter is not indicated for use in the prevention of deep vein thrombosis.Without the procedural films and post-implant imaging available for review, the reported events and a device malfunction could not be confirmed.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.Should additional information become available, the file will be updated accordingly.

• 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: 7549055
• MDR Text Key: 109399917
• Report Number: 1016427-2018-01495
• 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,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15747951
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.; UNKNOWN 5-FRENCH SHEATH.; UNKNOWN CATHETER.; UNKNOWN GUIDE WIRE.; UNKNOWN NEEDLE.
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR