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

Model Number 466FXXXX

Device Problems Fracture (1260); Defective Device (2588); Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100); Numbness (2415)

Event Date 05/19/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Additional information is pending and will be submitted in a follow up report when received.

Event Description

As reported by an updated legal brief, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to dvt and caval thrombosis.As a result of the malfunction, 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

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 deep vein thrombosis and caval thrombosis.The indication for the filter implant as well as any pertinent medical history has not been provided and 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 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.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 vessel characteristics.Inferior vena cava filters are not indicated for use in the prevention of deep vein thrombosis.There is nothing in the limited information provided 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis, pulmonary embolism and blood clots after a previous surgery. the filter was deployed via the patient's right common femoral vein.It was placed infrarenal area of the inferior vena cava.The filter was in a good position.The patient tolerated the procedure well with no evidence of immediate complication.  additional information received per the patient profile form (ppf) states that the patient experienced filter embedded other than in wall of the inferior vena cava (ivc), blood clot, clotting and or occlusion of the ivc, the device is unable to be retrieved and the filter is fractured.The patient became aware of the reported events eight years after the index procedure.There are no known attempts to remove the device.The patient states that he continues to experience blood clots in left leg, numbness in left leg and intermittent chest pain.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, b5, g4, g7, h1, h2 and h6.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 deep vein thrombosis (dvt) and caval thrombosis.The patient reported becoming aware of filter embedded other than in wall of the inferior vena cava (ivc), blood clot, clotting and or occlusion of the ivc, the device is unable to be retrieved and the filter is fractured, approximately eight years post implant.There patient indicated that there have been no attempts to remove the device.The patient also reports continuing to experience blood clots in the left leg, numbness in the left leg and intermittent chest pain.According to the medical record, the indication for the filter implant was a history of dvt and pulmonary embolism (pe) and was scheduled to undergo an unspecified orthopedic surgery.The patient was felt to be high risk for pe.The filter was placed via the right common femoral vein and deployed in the infrarenal ivc.The patient tolerated the procedure well with no evidence of immediate complication.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 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 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.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.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 vessel characteristics.Inferior vena cava filters are not indicated for use in the prevention of deep vein thrombosis.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.Extremity numbness and chest pain do not represent a device malfunction and may be related to underlying patient specific issues.There is nothing in the limited information provided 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.

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 deep vein thrombosis (dvt) and caval thrombosis.The patient reported becoming aware of filter embedded other than in wall of the inferior vena cava (ivc), blood clot, clotting and or occlusion of the ivc, the device is unable to be retrieved and the filter is fractured, approximately eight years post implant.There patient indicated that there have been no attempts to remove the device.The patient also reports continuing to experience blood clots in the left leg, numbness in the left leg and intermittent chest pain.According to the medical record, the indication for the filter implant was a history of dvt and pulmonary embolism (pe) and was scheduled to undergo an unspecified orthopedic surgery.The patient was felt to be high risk for pe.The filter was placed via the right common femoral vein and deployed in the infrarenal ivc.The patient tolerated the procedure well with no evidence of immediate complication.The patient has subsequently reported becoming aware of filter tilt approximately eight years post implant.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 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 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.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.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 vessel characteristics.Inferior vena cava filters are not indicated for use in the prevention of deep vein thrombosis.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.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Extremity numbness and chest pain do not represent a device malfunction and may be related to underlying patient specific issues.There is nothing in the limited information provided 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.

Event Description

Additional information received per an amended patient profile form (ppf) states that in addition to the previously reported events, the patient also experienced tilting of the filter.The patient became aware of the reported event approximately eight years after the index procedure.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• 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 ; 7863138372
• MDR Report Key: 9710052
• MDR Text Key: 188352005
• Report Number: 1016427-2020-03817
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2022
• 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
• Treatment: UNKNOWN 21-GAUGE NEEDLE; UNKNOWN 6 FRENCH DELIVERY SYSTEM; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male