MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

Device Problem Use of Device Problem (1670)

Patient Problems Perforation (2001); Depression (2361); No Code Available (3191)

Event Date 06/16/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, filter perforation.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.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.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.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.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, filter perforation.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

According to the information received in the patient profile from (ppf), the patient became aware of the events twelve years and ten months post implantation.The patient reports suffering from depression, pain, and cannot sleep for two to three days.The patient is taking the prescribed medications of valium, ativan, and ambien to assist with the reported symptoms.The patient has a history of obsessive compulsive disorder which the patient reports has gotten worse.The following additional information received per the medical records state that during the implant procedure, the right common femoral vein was accessed, and a wire was inserted.The needle was removed and a deployment sheath was inserted.A venogram was performed and the left renal vein was identified.The filter was then deployed without difficulty in an infrarenal position.The sheath was removed and hemostasis was achieved using direct pressure.The patient tolerated the procedure well and there were no immediate complications.

Manufacturer Narrative

Correction to product code.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, filter perforation.According to the information received in the patient profile from (ppf), the patient became aware of the events twelve years and ten months post implantation.The patient reports experiencing depression, pain, and cannot sleep for two to three days at a time.The patient is taking the prescribed medications of valium, ativan, and ambien to assist with the reported symptoms.The patient reports that pain to be excruciating and located in the mid to lower back and travels around to the abdomen on the right side.The patient is scheduled for a colonoscopy and an appointment with a neurosurgeon to evaluate the pain.The patient has a history of obsessive compulsive disorder which the patient reports has gotten worse.The indication for the filter implant was pulmonary embolism, where anticoagulants are contraindicated.The filter was placed via the right common femoral vein and deployed infrarenally below the level of the left renal vein.The patient is reported to have tolerated the procedure well with no immediate complications.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 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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.With the limited information available and without the procedural films or post implant images to review the reported device perforation of the inferior vena cava could not be confirmed or further clarified.A device malfunction has not been reported at this time.Anxiety, depression and insomnia do not represent a device malfunction and may be related to underlying patient specific issues.Anxiety and depression can often lead to issues with insomnia.Given the limited information currently available for review, 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: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7959996
• MDR Text Key: 123506568
• Report Number: 1016427-2018-01928
• Device Sequence Number: 0
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2018
• Patient Sequence Number: 1
• Patient Age: 48 YR