MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466FXXXX

Device Problems Fracture (1260); Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100)

Event Date 04/15/2016

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent placement of an optease permanent vena cava filter.The following additional information received per the patient profile form indicates that seven years and ten months post implantation the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc).The patient reports that the filter has lodged and suffers from depression.According to the medical records, the patient has a history of deep vein thrombosis (dvt) and pulmonary embolism (pe).The filter was successfully deployed during the index procedure without complications.

Manufacturer Narrative

After further review of additional information received the sections have been updated accordingly.As reported, the patient underwent placement of an optease permanent inferior vena cava (ivc) filter.Per the medical records, the patient has a history of deep vein thrombosis (dvt) and pulmonary embolism (pe).The filter was successfully deployed during the index procedure without complications.Per the patient profile form, seven years and ten months post implantation the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc).The patient reports that the filter has lodged and suffers from depression.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, no device analysis nor a device history record (dhr) 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 predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Blood clots and occlusive thrombosis within the filter do not represent a device malfunction.Depression does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient co-morbidities, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, 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.

Manufacturer Narrative

After further review of additional information received have been updated accordingly.It was reported that a patient underwent placement of an optease permanent vena cava filter.The information provided indicated that seven years and ten months post implantation the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc).The patient reports that the filter has lodged and suffers from depression and there is device deformation and possible fracture.The indication for the filter placement was a recent history of deep vein thrombosis (dvt) and pulmonary embolism (pe) and scheduled for surgery with a contraindication for anticoagulation.The filter was placed via the right femoral vein and deployed just distal to the renal vein inflow.The position of the filter was successfully confirmed.There were no complications noted during the procedure.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.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, reports of adverse clinical sequelae from filter fractures are rare.Filter fracture and altered shape was reported but could not be confirmed without procedural/follow up films for review.Blood clots, clotting and/or occlusion within ivc does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Depression does 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.Should additional information become available, the file will be updated accordingly.

• Brand Name: 466FXXXX
• 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: 7057981
• MDR Text Key: 92902627
• Report Number: 9616099-2017-01620
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Disability
• Patient Age: 42 YR