MAUDE Adverse Event Report: CORDIS CASHEL FEMORAL 55CM KIT; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	466F230AF
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Failure of Implant (1924); Perforation (2001); Perforation of Vessels (2135); Anxiety (2328)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem 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, inferior vena cava (ivc) perforation, filter migration, tilting of the filter, and embedment.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the filter was indicated for bilateral pulmonary emboli (pe) and deep vein thrombosis (dvt).An optease inferior vena cava filter was initially deployed below the renal veins; however, the filter moved downwards during placement.The filter was therefore successfully retrieved, and another (new) optease filter was then deployed below the renal veins without any difficulty.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately two years post implantation.The patient reports perforation of filter strut(s) outside the ivc, tilting of the filter, migration of the filter other than to the heart and filter embedded in wall of the ivc.The patient further asserts to have suffered from chest pain and tenderness when lying down, shortness of breath and experienced anxiety related to the filter.
Event or Problem 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, inferior vena cava (ivc) perforation, filter migration, tilting of the filter, and embedment.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.Additional information was provided, and per the implant records, the filter was indicated for bilateral pulmonary emboli (pe) and deep vein thrombosis (dvt).An optease inferior vena cava filter was initially deployed below the renal veins; however, the filter moved downwards during placement (b)(4)).The filter was therefore successfully retrieved without any other reported complications, and another (new) optease filter (b)(4)) was then deployed below the renal veins without any difficulty.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately two years post implantation.The patient reports perforation of filter strut(s) outside the ivc, tilting of the filter, migration of the filter other than to the heart and filter embedded in wall of the ivc.The patient further asserts to have suffered from chest pain and tenderness when lying down, shortness of breath and experienced anxiety related to the filter.
Additional 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 inferior vena cava (ivc) perforation, filter migration- initial filter, tilting of the filter, and embedment.The patient reported becoming aware of perforation of filter strut(s) outside the ivc, tilting of the filter, and filter embedded in wall of the ivc, approximately two years post implant.The patient also reports chest pain and tenderness when lying down, shortness of breath and anxiety related to the filter.According to the implant records, the filter was indicated for bilateral pulmonary emboli (pe) and deep vein thrombosis (dvt).An optease inferior vena cava filter was initially deployed below the renal veins; however, the filter moved downwards during placement and was removed.Another optease filter was then deployed below the renal veins without any difficulty.The patient tolerated the procedure well.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 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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implant.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.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Without procedural films for review, the reported filter tilt and perforation could not be confirmed nor a cause for the event(s) determined.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.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.It is unknown if the tilt contributed to the reported perforation.Chest pain, shortness of breath and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.With the very limited information and no imaging available for review it is not possible to draw a conclusion between the reported events and the filter.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: FEMORAL 55CM KIT
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9636861
• Report Number: 9616099-2020-03506
• Device Sequence Number: 16872223
• Product Code: DTK
• UDI-Device Identifier: 20705032072899
• UDI-Public: 20705032072899
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 466F230AF
• Device Catalogue Number: 466F230AF
• Device Lot Number: 17423568
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Age: 57 YR