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

Model Number 466P306X

Device Problems Use of Device Problem (1670); Migration (4003)

Patient Problem Perforation of Vessels (2135)

Event Date 09/14/2018

Event Type  Injury  

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 perforating the wall of the ivc.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

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 perforating the wall of the ivc.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.There is currently no additional information available for review.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.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.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.

Manufacturer Narrative

Correction to product code.

Manufacturer Narrative

As reported, the patient had a history of diabetes mellitus type ii, hypertension on peripheral neuropathy.The patient was admitted to hospital with left leg pain and swelling and was found to have an expanding left leg deep vein thrombosis and hyponatremia.The patient was started on heparin and coumadin and underwent a subsequent placement of a trapease vena cava filter.The filter was successfully placed in an infrarenal location at l2-l3.Approximately nine years and three months after the implantation, the patient had a computerized tomography (ct) scan that revealed multiple limbs of the filter perforating the wall of the inferior vena cava (ivc) with no evidence of adjacent structural organ injury.In addition, the patient reported pain in the midriff area, venous reflux.The patient further reported experiencing mental anguish.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 ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.The patient is also reported to have had a perforation of the ivc; though this could not be confirmed without procedural films for review.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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 the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Due to the nature of the complaint, the reported pain and venous reflux experienced by the patient could not be confirmed and the exact cause could not be determined.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, unease and worry.Given the limited information 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.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

According to the information received in the patient profile from (ppf), the patient became aware of the events approximately five years and ten months post implantation.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of filter strut(s) outside the ivc.The patient reports pain in the abdomen area and mental anguish.The patient states that they have venous reflux disease that may have been caused by the filter.The following additional information received per the medical records stat that the patient has a history deep vein thrombosis in the right leg which was the reason for filter placement.The patient also has a history of hyponatremia.During the implant procedure, the filter was placed in good position at the level of the right side of the l2 vertebral body.A ct scan of the patient¿s abdomen performed nine years and three months post implantation showed multiple struts of the filter perforating the wall of the inferior vena cava.There was no evidence of adjacent structural or organ damage.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7960010
• MDR Text Key: 123506468
• Report Number: 1016427-2018-01929
• 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,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: 03/14/2019
• Patient Sequence Number: 1
• Patient Age: 53 YR