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

Model Number 466FXXXX

Device Problems Difficult to Remove (1528); Material Perforation (2205)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Perforation of Vessels (2135); No Code Available (3191)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation of the filter and the resultant symptoms.The indication for the filter placement 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 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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Perforation of the ivc was reported, however a clinical conclusion could not be determined as to the cause of the event.Without post implant images for review, the reported filter perforation could not be confirmed nor a cause for the event determined.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications associated with ivc filters.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.

Event Description

As reported in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, physical and emotional damages from perforation of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, distress and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, a3, b3, b4, b6, b7, d11, g3, g4, g7, h1, h2 and h6.Additional information received per the medical records indicate that the patient has a history of acute pulmonary embolism.The filter was implanted prior to a planned dilation and curettage procedure.The filter was deployed via the patient's right side femoral vein.Venograms were done to locate the renal veins, and the filter was deployed into the infra-renal position.There were no reported complications.  additional information received per the patient profile form (ppf) states that there was an unsuccessful attempt to remove the device the same month it is was implanted.Approximately fourteen years after the index procedure, the patient experienced perforation of the filter struts outside of the inferior vena cava (ivc).The patient stated the that the device is embedded and she continues to experience mental anguish and paranoia.Additional information received per the medical records indicate that there was an attempt to remove the device one week after it is was implanted.Multiple snares were used from bilateral femoral approaches in an attempt to remove the filter.The filter was not able to be removed.After the procedure, the patient's blood pressure dropped to 50/25.After placing the patient in the trendelenburg position and starting intravenous fluids, the patient's blood pressure returned to 100/60.Medical records state that approximately fourteen years after the index procedure a computed tomography (ct) scan of the abdomen revealed a large calcification within the center of the filter and the legs of the filter extend beyond the margins of the ivc.Section h6: patient code '3191' was used for "large calcification within the center of the filter".Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of acute pulmonary embolism (pe).The indication for the filter placement was reported to be as prophylaxis prior to a planned dilatation and curettage procedure.The filter was implanted via the right femoral vein and placed in an infrarenal position.The patient was reported to have tolerated the procedure well and without complications.Six days after the filter implantation, the patient underwent an unsuccessful percutaneous attempt to remove the filter with the use of multiple snares.The procedure was associated with hypotension required treatment with intravenous fluids.Approximately fourteen years after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed calcification within the center of the filter with filter struts extending beyond the inferior vena cava (ivc).The patient indicated that the filter was embedded.The patient further reported having experienced mental anguish and paranoia 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 optease retrievable vena cava filter is indicated for use in the prevention of recurrent 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 procedural films for review, the reported retrieval difficulty and ivc perforation events could not be confirmed and the exact cause could not be determined.The reported details indicate that retrieval was attempted six days after implantation.Retrieval of the optease retrievable vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as twelve days.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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.Without images or procedural films for review, the reported filter stenosis or calcification could not be confirmed and the exact cause could not be determined.Due to the nature of the complaint, the reported hypotension 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.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: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9530604
• MDR Text Key: 182571927
• Report Number: 1016427-2019-03708
• 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: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER; UNKNOWN DILATOR; UNKNOWN GUIDE WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 43 YR