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); Thrombosis (2100)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Information is pending and will be submitted in a follow up report when received.

Event Description

As reported by the legal team, the patient underwent placement of the' trapease vena cava filter.That filter is still in place, and recent studies confirm the filter now presents more risks than benefits, including an increased risk of forming a blood clot.The extent of the device failure has not been fully documented by the patient's treating medical provider(s).As a result of the malfunction, the patient has or may suffer life-threatening injuries and damages and require extensive medical care and treatment.The patient has or may suffer and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.The patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots, and may need a risky surgery to attempt to remove the filter.According to the information received in the patient profile from (ppf), the patient became aware of the reported events six years and two months post implantation.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, post implant pulmonary embolism and deep vein thrombosis, and shortness of breath.The patient lives with fear of possible device failure in the future.The following additional information received per the medical records state that the patient has a history of pulmonary embolism.During the implant procedure, the right common femoral vein was accessed with a micropuncture needle and a wire was passed through.An introducing sheath was then advanced over the wire and the filter was deployed in an infrarenal position.The patient tolerated the procedure well.

Manufacturer Narrative

As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of pulmonary embolism.The filter was deployed in an infrarenal position.The patient tolerated the procedure well.Per the patient profile from (ppf), the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, post implant pulmonary embolism and deep vein thrombosis, and shortness of breath.The patient lives with fear.The filter remains implanted; thus, unavailable for analysis.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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Post procedure pulmonary embolism is a known potential adverse event associated with the use of the ivc filters.These events may be related to excessive clot burden from underlying patient specific factors.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.

• 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: 8366379
• MDR Text Key: 137015135
• Report Number: 1016427-2019-02547
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/29/2019
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Device Lot Number: 15153991
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 03/29/2019
• Patient Sequence Number: 1
• Patient Age: 81 YR