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

Model Number 466FXXXX

Device Problems Difficult to Remove (1528); Protective Measures Problem (3015)

Patient Problems Pulmonary Embolism (1498); Cellulitis (1768); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter five years and eight months ago.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, post-implant deep vein thrombosis, pulmonary embolism, and thrombosis.The filter remains implanted; thus, unavailable for analysis.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, pulmonary emboli and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, 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.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter five years and eight months ago.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, post-implant deep vein thrombosis, pulmonary embolism, and thrombosis.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 proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

According to the information received in an amended patient profile from (ppf), the patient became aware of the events approximately three years post implantation.No exact date was provided.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter five years and eight months ago.The information provided indicated that the filter malfunctioned and caused post-implant deep vein thrombosis, pulmonary embolism, and thrombosis.The patient reported that the device is unable to be retrieved and that there are blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).The patient is also reported to have experienced poor circulation and leg pain below the filter site, cellulitis in the left lower leg, swelling of the lower legs, unable to wear certain clothing due to appearance of the injuries, psychological injuries or mental anguish.The indication for the filter implant was a patient known to have a hypercoagulable state, with a history of deep vein thrombosis (dvt) and pulmonary embolism (pe), still with dvt in the left superficial femoral vein and has experienced a gastro-intestinal bleed, therefore unable to take anti-coagulants.The filter was placed under fluoroscopic guidance below the level of the renal veins.There were no complications and the patient tolerated the procedure well.Approximately five years post implant an unsuccessful percutaneous removal attempt was made.The procedural details have not been provided and there is currently no additional information available for review.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.Following implant, 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, making retrieval difficult.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported event.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling of the affected extremity.The skin of the lower legs can become thick, dry, and fragile.This may lead to ulceration of the skin - usually on the inside aspect of the leg just above the ankle.Cellulitis is inflammation of subcutaneous tissue.Risk factors for cellulitis include diseases that affect blood circulation in the legs and feet, such as chronic venous insufficiency and varicose veins, are also risk factors for cellulitis.Severe cellulitis infection may damage tissue around the lymph nodes or vessels.This may lead to scarring, increasing the risk of lymphedema.Some patients with cardiovascular diseases have a higher risk of developing lymphedema, such as dvt (deep vein thrombosis), venous leg ulcers, and varicose veins.Without post implant imaging available for review, the reported events could not be confirmed or further clarified.The optease vena cava filter is not indicated for use in the prevention of deep vein thrombosis.Anxiety 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.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter five years and eight months ago.The information provided indicated that the filter malfunctioned and caused post-implant deep vein thrombosis, pulmonary embolism, and thrombosis.The patient reported that the device is unable to be retrieved and that there are blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).The patient is also reported to have experienced poor circulation and leg pain below the filter site, cellulitis in the left lower leg, swelling of the lower legs, unable to wear certain clothing due to appearance of the injuries, psychological injuries or mental anguish.The indication for the filter implant was a patient known to have a hypercoagulable state, with a history of deep vein thrombosis (dvt) and pulmonary embolism (pe), still with dvt in the left superficial femoral vein and has experienced a gastro-intestinal bleed, therefore unable to take anti-coagulants.The filter was placed under fluoroscopic guidance below the level of the renal veins.There were no complications and the patient tolerated the procedure well.Approximately five years post implant an unsuccessful percutaneous removal attempt was made.The procedural details have not been provided and there is currently no additional information available for review.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.Following implant, 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, making retrieval difficult.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported event.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling of the affected extremity.The skin of the lower legs can become thick, dry, and fragile.This may lead to ulceration of the skin - usually on the inside aspect of the leg just above the ankle.Cellulitis is inflammation of subcutaneous tissue.Risk factors for cellulitis include diseases that affect blood circulation in the legs and feet, such as chronic venous insufficiency and varicose veins, are also risk factors for cellulitis.Severe cellulitis infection may damage tissue around the lymph nodes or vessels.This may lead to scarring, increasing the risk of lymphedema.Some patients with cardiovascular diseases have a higher risk of developing lymphedema, such as dvt (deep vein thrombosis), venous leg ulcers, and varicose veins.Without post implant imaging available for review, the reported events could not be confirmed or further clarified.The optease vena cava filter is not indicated for use in the prevention of deep vein thrombosis.Anxiety 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
• MDR Report Key: 7856125
• MDR Text Key: 119563456
• Report Number: 1016427-2018-01783
• 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,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• 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
• Date Manufacturer Received: 04/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 6FRENCH SHEATH
• Patient Age: 72 YR