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 Occlusion (1984); Swelling (2091); Thrombosis (2100); No Code Available (3191)

Event Date 02/23/2012

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of an optease retrievable inferior vena cava (ivc) filter.The indication for the filter placement was recurrent pulmonary embolism (pe) and non-compliance with anti-coagulant therapy.The filter was implanted at the l1-l2 interspace via the right internal jugular vein.A summary of the implant procedure indicated that the vena cava was patent and the filter was placed satisfactorily.Approximately seven and a half years later the patient was experiencing leg pain and swelling.A magnetic resonance angiogram (mra)was performed, it is unclear what the imaging revealed.The patient then presented to the emergency room for further workup and treatment of the leg pain.At that time, it was noted that the patient had symptomatic venous insufficiency in the lower extremities.The patient was evaluated for possible filter retrieval, an inferior vena cavogram was performed and it was noted that the filter hook was embedded in the wall of the ivc and removal would be nearly impossible.The patient was advised the filter could not be removed and was ordered to begin long-term anticoagulation and that ongoing monitoring would be necessary.On or around that same time, the filter was removed percutaneously.As reported the information received also indicates that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter embedded in wall of the ivc and unable to be retrieved.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.Additional information contained on the patient profile form (ppf) indicated that two years and four months post implantation, the patient had blood clots, clotting, and occlusion of the ivc and that the filter was clogged.On or about seven years and five months post implantation the patient had the filter removed.The patient reports that two years and five months post implantation the patient suffered from leg pain and swelling and venous insufficiency of the lower extremities.The patient also reports to be suffering from emotional distress, mental anguish and lower abdominal pain.There is currently no additional information available.The product was not returned for analysis as the current disposition is unknown.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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 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 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.Blood clots and thrombosis within the filter do not represent a device malfunction.Without the procedural films and post implant imaging available to review, the reported blood clots, clotting, occlusion, retrieval difficulty and embedded could not be confirmed.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling of the legs.Anxiety and pain do not represent a device malfunction and may be related to underlying patient specific issues.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.This report is a follow up report to mfr number 9616099-2016-00488 that was submitted under the previous complaint handling software system.The information has been duplicated from the first report with additional information added.

Event Description

As reported by the legal brief, the patient underwent placement of an optease retrievable inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter embedded in wall of the ivc and unable to be retrieved.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.The following additional information received per the patient profile from (ppf) indicates that two years and four months post implantation, the patient had blood clots, clotting, and occlusion of the ivc and that the filter was clogged.On or about seven years and five months post implantation the patient had the filter removed.The patient reports that two years and five months post implantation the patient suffered from leg pain and swelling and venous insufficiency of the lower extremities.The patient also reports to be suffering from emotional distress, mental anguish and lower abdominal pain.According to the medical records, the patient had a history of recurrent pulmonary emboli and the patient had not been compliant with anticoagulation.The filter was successfully deployed in the l1-2 interspace during the index procedure.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7107642
• MDR Text Key: 94482483
• Report Number: 1016427-2017-00872
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• 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: R1108415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Date Device Manufactured: 11/24/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 41 YR