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

Catalog Number 466F220A

Device Problem Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Swelling (2091); Perforation of Vessels (2135)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.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.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

As reported by the legal brief, the patient underwent placement of a 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 tilting of the filter and the struts appear to expand outside of the inferior vena cava wall.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.Information received per the medical records indicate that the patient has a history of right leg deep vein thrombosis while on anticoagulation therapy.During the index procedure, the filter was deployed via the right femoral vein.He patient tolerated the procedure well.  information received per the patient profile form (ppf) states that approximately eight years and five months after the index procedure the patient began to experience tilting of the filter, blood clots, clotting and/or occlusion of the inferior vena cava.The patient's right leg has a blood clot.The leg is swollen, hurts and the skin is broken due to the swelling.The patient continues to worry about the filter.The form also states that the device is unable to be removed; however, there have been no attempt to remove the filter.

Manufacturer Narrative

It was reported that a patient underwent placement of a optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting of the filter and the struts appear to expand outside of the inferior vena cava wall.The information received indicated that approximately eight years and five months after the index procedure the patient began to experience tilting of the filter, blood clots, clotting and or occlusion of the inferior vena cava.The patient's right leg has a blood clot.The leg is swollen, hurts and the skin is broken due to the swelling.The patient continues to worry about the filter.The form also states that the device is unable to be removed; however, there have been no attempt to remove the filter.The indication for the filter implant was an extension of a right lower leg deep vein thrombosis, despite anticoagulation.The filter was placed via the right femoral vein and deployed without complications.The patient is reported to have tolerated the procedure well.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 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, thrombosis in the filter and occlusion of the ivc do not represent a device malfunction, rather clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Without procedural films or post-implant images for review, the reported filter tilt, and perforation of the ivc could not be confirmed.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Anxiety, swelling and pain of the leg does not represent a device malfunction and may be related to underlying patient specific issues, in particular, the patient¿s history of dvt.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

• 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: 7961906
• MDR Text Key: 123564227
• Report Number: 1016427-2018-01931
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: 466F220A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2018
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE; UNKNOWN SHEAT; UNKNOWN GUIDE WIRE; UNKNOWN SHEAT
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 60 YR