MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CS; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Perforation (2001); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 04/19/2017

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 damage to the patient including, but not limited to tilt and perforation of the inferior vena cava filter (ivc) filter.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) 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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.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.

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 damage to the patient including, but not limited to tilt and perforation of the inferior vena cava filter (ivc) filter.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 results, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of myocardial infarction and deep vein thrombosis despite anticoagulation.The filter was successfully deployed via the patient's femoral vein.A computed tomography (ct) scan was performed for evaluation of the patient¿s trapease filter.The results reported tilt and perforation.A later consultation informed the patient that due to his thrombus complications, he was advised against retrieval of the filter.  additional information received per the patient profile form (ppf) states that the patient experienced thrombus, perforation of filter strut(s) outside the inferior vena cava (ivc), tilting of the filter, blood clots, clotting and/or occlusion of the ivc.These injuries have caused emotional distress, mental anguish, anxiety and stress.The form states that the filter was unable to be retrieve, but there were no documented retrieval attempts.As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of myocardial infarction.The indication for the filter implantation was reported to be a development of a deep vein thrombosis (dvt) despite anticoagulation.The filter was implanted via the right femoral vein and successfully deployed in the inferior vena cava (ivc).Approximately seven years and ten months after implantation, the patient became aware that they had developed thrombus, clotting and/or occlusion of the ivc.The filter was also associated with filter tilt and perforation of the strut(s) outside the ivc.A computerized tomography (ct) scan is reported to have confirmed this tilt and perforation.Later medical consultation advised against filter retrieval due to the patient¿s previous thrombus complications.No attempts to retrieve the filter were documented.The patient reported experiencing emotional distress, mental anguish and stress as a result of these events.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.Without images or procedural films for review, the reported filter tilt and ivc perforation could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.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.Blood clots and thrombosis/occlusion within device or within the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CS
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8460306
• MDR Text Key: 140177369
• Report Number: 1016427-2019-02654
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0808571
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR
• Patient Weight: 86