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 Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100)

Event Date 11/05/2015

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot (r0805209) presented no issues during the manufacturing process that can be related to the reported event.The device¿s expiration date is july 2008.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease permanent vena cava filter.The following additional information received per the patient profile from (ppf) indicates that nine years and ten months post implantation, the patient had blood clots, clotting, occlusion of the inferior vena cava (ivc), and that the device was unable to be removed.There have been no known attempts on records to remove the filter.The patient also reports to have localized pain at the implantation site, chronic anxiety and panic.According to the medical records, the patient had acute pancreatitis, right lower extremity deep vein thrombosis (dvt) was on a ventilator and in respiratory failure.The patient was on therapeutic intravenous heparin however a computerized tomography (ct) scan revealed the thrombus had progressed to the right common iliac vein and the great vessel.Therefore, the filter was successfully deployed during the index procedure at the level between the second and third lumbar vertebrae.The patient tolerated the procedure well.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.It was reported that a patient underwent placement of a trapease permanent vena cava filter.The indication for the placement was right lower extremity deep vein thrombosis (dvt).The patient¿s medical history is significant for acute pancreatitis and respiratory failure requiring mechanical ventilation.The patient was on therapeutic intravenous heparin however a computerized tomography (ct) scan revealed the thrombus had progressed to the right common iliac vein and the great vessel.Therefore, the filter was successfully deployed via the left common femoral vein during the index procedure at the level between the second and third lumbar vertebrae.The patient tolerated the procedure well.Additional information contained in the patient profile from (ppf) indicated that nine years and ten months post implantation the patient had blood clots, clotting, occlusion of the inferior vena cava (ivc), and that the device was unable to be removed.There have been no known attempts on records to remove the filter.The patient also reports to have localized pain, in the neck, at the implantation site, although the medical records indicate that the device was placed via the left femoral vein.The patient is also reported to be experiencing chronic anxiety and panic.There is currently no additional information 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.Blood clots, clotting, 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 event of retrieval difficulty or a device malfunction could be confirmed, nor is it possible to establish a relationship between the reported events and the device.Anxiety and pain do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, 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; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7156302
• MDR Text Key: 96111361
• Report Number: 1016427-2017-00926
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: R0805209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 12/30/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2005
• 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; Disability
• Patient Age: 50 YR