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

Catalog Number 466FXXXX

Device Problem Fracture (1260)

Patient Problems Embolus (1830); Occlusion (1984); Perforation of Vessels (2135); Injury (2348)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.Occupation: other, senior counsel, litigation.It was reported that a patient underwent placement of an optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to fracturing of the filter.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.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Without imaging available for review the reported filter fracture could not be confirmed, nor is it possible to draw a conclusion as to what may have contributed to the reported events.At this time, there is nothing to suggest 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.Please note that this is the initial/final report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to fracturing of the filter.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis, chest pain and shortness of breath.  the filter was deployed via the patient's right femoral vein.During the procedure, the guide wire did not pass easily through the inferior vena cava (ivc).A cavagram revealed that there was poor flow in the ivc with marked thrombosis of the ivc below the level of the renal arteries.The filter was deployed so that it was just below the level of the renal arteries and just superior to the thrombus.A repeat vena cavagram demonstrated proper positioning of the filter.The patient tolerated the procedure well without immediate complications.Approximately ten years six months after the index procedure the patient had computed tomography (ct) scans.The indication for the computed tomography (ct) scan was abdominal pain and gastrointestinal bleeding.The scans revealed the following: there is a metallic wire proximal to the filter that may represent a guide wire fragment or part of delivery device (the wire measures close to 5 cm in length, extending inferiorly from the tip of the filter), retroperitoneal venous collateral suggesting ivc occlusion, intrauterine device appears to be lower than expected with the tip at the level of the uterine cervix, a clip in the region of the left adnexa may be a migrated clip or dropped clip from cholecystectomy, the patient had hardware in the proximal left femur, hepatic steatosis, splenomegaly, dilation of the main portal vein at 20 mm questionable for portal hypertension, 8 mm nodule in the right lower lobe medial costophrenic sulcus, diverticulosis in the sigmoid colon and minimal subsegmental atelectasis at the lung base.Additional information received per the patient profile form (ppf) states that the patient experienced filter fracture, perforation of filter strut(s) outside the inferior vena cava, blood clots, clotting, and/or occlusion of the inferior vena cava.The patient believes that the fractured filter struts are being retained in his right groin area.The patient has also experienced severe pain and suffering as well as stress and anxiety due to fractured filter, occlusion and retained strut.  additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the patient experienced filter fracture, perforation of filter strut(s) outside the inferior vena cava, blood clots, clotting, and/or occlusion of the inferior vena cava.The patient feels that the fractured filter struts are being retained in the right groin area.The patient also reports experiencing severe pain as well as stress and anxiety due to fractured filter, occlusion and retained strut.The indication for the filter implant was deep vein thrombosis.The filter was placed via the right femoral vein.An attempt was made to pass a wire through the inserted sheath, but it would not pass, an ensuing venocavogram was performed and demonstrated poor flow with marked thrombosis in the vena cava below the level of the renal veins.The filter was then deployed below the level of the renal arteries and just superior to the thrombus.The patient reportedly tolerated the procedure well with no immediate complications.Approximately ten years and six months post implant the patient had computed tomography (ct) scan performed for complaints of abdominal pain and bleeding.Results of the scan noted; a metallic wire proximal to the filter that may represent a guide wire fragment or part of delivery device (the wire measures close to 5 cm in length, extending inferiorly from the tip of the filter), retroperitoneal venous collateral suggesting ivc occlusion, intrauterine device appears to be lower than expected with the tip at the level of the uterine cervix, a clip in the region of the left adnexa may be a migrated clip or dropped clip from cholecystectomy, the patient had hardware in the proximal left femur, hepatic steatosis, splenomegaly, dilation of the main portal vein at 20 mm questionable for portal hypertension, 8 mm nodule in the right lower lobe medial costophrenic sulcus, diverticulosis in the sigmoid colon and minimal subsegmental atelectasis at the lung base.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.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.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 12 days.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Clinical factors that may have influenced the events include patient, pharmacological, procedural and lesion characteristics.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.However, review of the information provided suggests that the snare used to retrieve the filter was what fractured, not the filter.Without the implant or attempted explant procedural details or imaging, to review, it is not possible to draw a conclusion between the reported events and the device.However, procedural factors and/or vessel characteristics may have contributed to the events.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.Given the limited information available for review, a relation between the device and the event could not be determined.At this time, there is nothing to suggest 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: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8092002
• MDR Text Key: 128026237
• Report Number: 1016427-2018-02287
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 04/01/2019; 05/02/2019
• Supplement Dates FDA Received: 04/30/2019; 05/31/2019
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 GUIDE WIRE; UNKNOWN 5 FRENCH DILATOR
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 35 YR