MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F220A

Device Problems Occlusion Within Device (1423); Difficult to Remove (1528)

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date in date of event is the complaint awareness date.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: two life-threatening episodes of ivc and filter thrombosis which necessitated hemodialysis due to acute renal failure from renal venous obstruction, followed by a difficult removal procedure.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.No additional information is available.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The optease 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 or records available for review, the reported events could not be confirmed.Thrombosis within the device or the inferior vena cava does not represent a device malfunction.Renal vein thrombosis is a thrombosis in the vein that drains blood from the kidney.Due to the inferior renal vein placement of the ivc filter, this type of thrombosis does not represent a device malfunction.Clinical factors that may have influenced these events include patient, pharmacological, comorbidities and lesion characteristics.The implantation date of the filter and the retrieval date is unknown at this time.Retrieval of the optease vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's 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, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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 through the legal department via legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: two life-threatening episodes of ivc and filter thrombosis which necessitated hemodialysis due to acute renal failure from renal venous obstruction, followed by a difficult removal procedure.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.No additional information is available.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly.It was reported that a patient underwent placement of an optease inferior vena cava (ivc) filter.The information provided indicated that the filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to, ivc and filter thrombosis which necessitated hemodialysis due to acute renal failure from renal venous obstruction, followed by a difficult removal procedure.The patient experienced blood clots, clotting and the patient underwent thrombolysis.The indication for the filter implant was significant pulmonary embolism and significant iliofemoral deep vein thrombosis in a female that was nine weeks pregnant.The filter was placed suprarenal due to the pregnancy.The filter was placed via the left jugular vein and deployed just above the level of the renal veins.Approximately six years and six months post implant the patient presented for removal of her ivc filter and it was discovered that chronic thrombus remained within the filter.The cordis optease filter was removed and a filter from another manufacturer was replaced in the infrarenal position because of her hypercoagulable state and previous thrombotic problems.There is currently no additional information available for review.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 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 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.Usage of the product other than that indicated in the product's 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 12 days.Blood clots, clotting and thrombosis within the inferior vena cava and/or the filter and surrounding vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.With the limited information available for review it is not possible to draw a clinical conclusion between the device and the reported events.However, the patient¿s reported hypercoagulability may have contributed to the reported events.Without the procedural details of the device retrieval it is not possible to ascertain what might have contributed to the reported retrieval difficulty.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 date provided was (b)(6) 2016.Health professional? no.Occupation: litigation paralegal.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary ; EI
• MDR Report Key: 7624961
• MDR Text Key: 111876650
• Report Number: 1016427-2018-01562
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F220A
• Device Lot Number: R0608149
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/25/2018
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 36 YR