MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: 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 perforation of filter strut(s) beyond the wall of the ivc.The indication for the filter implant has not been provided and 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.The timing and mechanism of the perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.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 including, but not limited to: perforation of filter strut(s) beyond the wall of the ivc.As a direct and proximate result of these malfunctions, patient suffered life-threatening, injuries and damages, and required extensive medical care and treatment.As a further proximate result patient has suffered and will continue to suffer significant medical expenses, pain and suffering.And other damages.

Manufacturer Narrative

According to the information received in the patient profile form (ppf), the patient became aware of the reported events nine years and three months post implant.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 also reports leg and ankle swelling daily, shortness of breath and increased heart rate.The patient gets dizzy when turning into a hallway too fast.The patient reports bulging veins in several places such as legs, arms, and across the chest, as well as stress.Per the information provided in the medical records, the patient has a medical history of acute dvt, thrombosis and extensive thrombus involving the iliac veins.An ivc filter was requested to be placed.During the implant procedure, the right internal jugular vein was accessed.The trapease filter was deployed with the apex located below the renal veins.A ct scan of the patient¿s abdomen was performed nine years and three months post implant.The infrarenal inverior vena cava filter was shown with at least one prong extending minimally outside the contour of the inferior vena cava wall.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of acute deep vein thrombosis (dvt) and extensive thrombus involving the iliac veins.The filter was implanted via right internal jugular vein and placed in an infrarenal position.Approximately nine years and three months after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed that at least one strut extended 3.1cm outside the contour of the infrarenal (ivc).The patient also reported stenosis.The patient further reported having experienced mental anguish, stress, dizziness, daily leg and ankle swelling, bulging veins (involving the arms, legs and chest), shortness of breath and an increased resting heart rate associated with the filter.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 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.Without images or procedural films for review, the reported filter ivc perforation could not be confirmed and the exact cause could not be determined.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.Due to the nature of the complaint, the reported swelling and shortness of breath experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Collateral circulation is the circulation of blood established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.It does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter.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, mental anguish, fear, 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.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9485290
• MDR Text Key: 173934298
• Report Number: 1016427-2019-03686
• Device Sequence Number: 1
• 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
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: .035 WIRE; GAUGE NEEDLE
• Patient Outcome(s): Life Threatening
• Patient Age: 74 YR