MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN OPTEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number UNKFILTER

Device Problems Fracture (1260); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Perforation (2001); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and the event date is the complaint awareness date.Implant date: only a year was provided - 2007.Occupation: other, senior counsel, litigation.It was reported that a patient underwent placement of an unknown 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, embedment, perforation, fracture, inferior vena cava stenosis and caval occlusion.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.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.An inferior 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 predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.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.The instructions for use (ifu) states 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.Without procedural films or post implant imaging available for review, the reported filter fracture, 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.Stenosis is an abnormal narrowing in a blood vessel, with the limited information provided it is not possible to determine what factors may have contributed to the reported stenosis and occlusion.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter.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.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 an unknown 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, embedment, perforation, fracture, inferior vena cava stenosis and caval occlusion.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.

Manufacturer Narrative

After further review of additional information received the following sections a2, b3, b5, g4, g7, h1, h2, and h6 have been updated accordingly.Event: according to the information received in the patient profile form (ppf), approximately on or about ten years post implantation of the ivc filter the patient became aware of the alleged events and reports to have a fractured filter, perforation of filter struts outside the ivc, tilt, filter embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc, and ivc stenosis.The patient states that the fractured filter struts are retained in their body and no attempt has been made to retrieve the filter.Complaint conclusion: it was reported that a patient underwent placement of an unknown vena cava filter.The information provided indicated that the following events occurred, filter fractured, perforation of filter struts outside the ivc, tilt, filter embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc, and ivc stenosis.The patient stated that the fractured filter struts are retained in their body and no attempt has been made to retrieve the filter.The patient reportedly became aware of the events approximately ten years post implant.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.An inferior 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 predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.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, clotting and/or occlusion of the inferior vena cava or the filter does not represent a device malfunction.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.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.The instructions for use (ifu) states 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.Without procedural films or post implant imaging available for review, the reported filter fracture, 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.Stenosis is an abnormal narrowing in a blood vessel, with the limited information provided it is not possible to determine what factors may have contributed to the reported stenosis and occlusion.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter.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.

Event Description

As reported by a second legal brief, the patient underwent placement of an 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 filter perforation.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, pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, b5, d1, d6, g3, g4, g6, h1, h2 and h6.It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the following events occurred, filter fractured, perforation of filter struts outside the ivc, tilt, filter embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc, and ivc stenosis.The patient stated that the fractured filter struts are retained in their body and no attempt has been made to retrieve the filter.The patient reportedly became aware of the events approximately ten years post implant.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.An inferior 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 predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.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, clotting and/or occlusion of the inferior vena cava or the filter does not represent a device malfunction.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.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.The instructions for use (ifu) states 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.Without procedural films or post implant imaging available for review, the reported filter fracture, 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.Stenosis is an abnormal narrowing in a blood vessel, with the limited information provided it is not possible to determine what factors may have contributed to the reported stenosis and occlusion.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter.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.Modified data based on new information: section d1: device changed from unknown filter to unknown optease filter.Section d6: implant date changed from 2007 to (b)(6) 2006.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8354064
• MDR Text Key: 136640764
• Report Number: 9616099-2019-02737
• Device Sequence Number: 2
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKFILTER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 27 YR