MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problem Defective Device (2588)

Patient Problems Coagulation Disorder (1779); Occlusion (1984)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

According to the information received in the patient profile from (ppf), the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting, and/or occlusion of the ivc.The patient reports difficulty sleeping because of worry that the filter will fracture or migrate.The following additional information received per the medical records state that the patient has a history of pulmonary embolisms.During the implant procedure, the right common femoral vein was accessed and a guidewire was inserted.A 6 french sheath was then placed over the guidewire.A 5 french pigtail catheter was advanced and the filter was deployed below the level of the renal veins.The patient tolerated the procedure well without complications.A ct scan of the patient¿s abdomen performed eight years and six months post implant show that the filter was in good position and no complications were noticed.

Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant a optease¿ vena cava filter ("optease¿ filter") for the treatment of pulmonary embolism.The device that was implanted into the patients left internal iliac veins.The device in the patient was positively identified by the patient's medical records as ref no.: 468f220a, lot no.: r0607331.The patient, had a scan done which showed his inferior vena cava (ivc) filter still present in him.The scan was done due to a worry about the potential migration of his ivc filter.As of the present, the patient is still implanted with the implanted device, which is known to be dangerous and cause serious side effects.As the result of the optease¿ filter installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside his body.According to the information received in the patient profile from (ppf), the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting, and/or occlusion of the ivc.The patient reports difficulty sleeping because of worry that the filter will fracture or migrate.The following additional information received per the medical records state that the patient has a history of pulmonary embolisms.During the implant procedure, the right common femoral vein was accessed and a guidewire was inserted.A 6 french sheath was then placed over the guidewire.A 5 french pigtail catheter was advanced and the filter was deployed below the level of the renal veins.The patient tolerated the procedure well without complications.A ct scan of the patient¿s abdomen performed eight years and six months post implant show that the filter was in good position and no complications were noticed.

Manufacturer Narrative

As reported, the patient underwent implant of an optease¿ vena cava filter for the treatment of pulmonary embolism.Per the medical records, the patient has a history of pulmonary embolisms.During the implant procedure, the filter was deployed below the level of the renal veins.The patient tolerated the procedure well without reported complications.As of the present, the patient is still implanted with the implanted device.Per the patient profile from (ppf), the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting, and/or occlusion of the ivc.The patient reports difficulty sleeping because of worry.The filter remains implanted; thus, unavailable for analysis.A ct scan of the patient¿s abdomen performed eight years and six months post implant show that the filter was in good position and no complications were noticed.The scan was done due to a worry about the potential migration of his ivc filter.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 optease 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.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: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8202965
• MDR Text Key: 131699042
• Report Number: 1016427-2018-02371
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Device Lot Number: R0607331
• Date Manufacturer Received: 02/01/2019
• Patient Sequence Number: 1
• Patient Age: 61 YR