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

Catalog Number 466FXXXX

Device Problem Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); Bowel Perforation (2668)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.Occupation: other, senior counsel, litigation.As reported, the patient underwent placement of an optease vena cava filter.The indication for the filter placement was not reported.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, perforation of the filter prongs through the inferior vena cava wall, hook embedment and perforation of the duodenum.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 inferior vena cava (ivc) 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.Without procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The brief also reported perforation of the ivc and perforation of the duodenum.However, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforations.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.The legal brief further noted that the filter was embedded in the vessel wall.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 twelve days.Given the limited information available for review, 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.Please note that this is the initial/final report for this product.

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, perforation of the filter prongs through the inferior vena cava wall, hook embedment and perforation of the duodenum.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly.Additional information received per the medical records indicate that the patient has a history of shortness of breath, syncope event prior to hospital admission, small pulmonary embolus in lower lobe pulmonary artery on left side, deep vein thrombosis and patient is unable to continue anticoagulation therapy due to gastrointestinal bleeding.The filter was deployed via the right side jugular vein.The filter was placed in the infrarenal area of the inferior vena cava at the l2 level.The device was in a satisfactory position below the bilateral renal arteries.During this same procedure an intravenous catheter was successfully placed in the superior vena cava.Additional information received per the patient profile form (ppf) states that the device is unable to be retrieved, there have been no attempts to remove the device.As reported, the patient underwent placement of an optease vena cava filter.The patient is reported to have had a pre-implant history of gastric bypass, shortness of breath, syncope with fall and headache, small pulmonary embolus in the left pulmonary artery and deep vein thrombosis.In addition, the patient is reported to have been unable to continue anticoagulation therapy due to gastrointestinal bleeding.The filter was deployed via the right jugular vein in the infrarenal area of the inferior vena cava (ivc) at the l2 level.The device was in a satisfactory position below the renal arteries.During this same procedure, a right internal jugular intravenous catheter was placed.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, perforation of the filter prongs through the ivc wall, hook embedment and perforation of the duodenum.Additional information received indicates that the filter could not be retrieved and that no attempts were made to remove the device.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 ivc 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.Without procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The brief also reported perforation of the ivc and perforation of the duodenum.However, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforations.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.The legal brief further noted that the filter was embedded in the vessel wall.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 twelve days.Given the limited information available for review, 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: OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 7901798
• MDR Text Key: 121464659
• Report Number: 1016427-2018-01870
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 10/04/2018
• Supplement Dates FDA Received: 10/29/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other