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

Model Number 466FXXXX

Device Problem Failure to Align (2522)

Patient Problems Calcium Deposits/Calcification (1758); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Stenosis (2263)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown.If received it will be provided.Complaint conclusion: as reported, the patient underwent placement of the optease vena cava filter.The indication for the filter placement was not reported.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from filter tilting and calcification and the resultant symptoms.As a direct and proximate result, 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.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 images or 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.Calcification is the accumulation of calcium salts in a body tissue.It is transported through the blood stream.Calcification normally occurs in the formation of bone, but calcium can be deposited abnormally in any part of the body, causing it to harden.Calcification within a patient does not represent a device malfunction.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.

Event Description

As reported by the legal department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from filter tilting and calcification and the resultant symptoms.As a direct and proximate result, 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

The catalog number is unknown; if received, it will be provided.Concomitant products: unkown 6f sheath and angled glidewire complaint conclusion: as reported, the patient underwent placement of an optease vena cava filter.The patient is reported to have had a history of morbid obesity.The indication for the filter placement was not reported.The filter was implanted via the right common femoral vein and was deployed below the renal veins and above the iliac bifurcation.Approximately one month after the implantation, the patient became aware that the filter had tilted and was associated with calcification, blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and ivc stenosis.The patient also experienced recurrent deep vein thrombosis (dvt) and associated with lower extremity and right lower quadrant pain.The patient underwent treatment with thrombolysis.The patient reported experiencing mental anguish and worry about possible filter complications.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 images or 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.Blood clots and thrombosis/occlusion within the ivc do not represent a device malfunction.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.These events do not represent a malfunction of the device.Calcification is the accumulation of calcium salts in a body tissue.It is transported through the blood stream.Calcification normally occurs in the formation of bone, but calcium can be deposited abnormally in any part of the body, causing it to harden.Calcification within a patient does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, unease and worry.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.

Event Description

As reported by the legal department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from filter tilting and calcification and the resultant symptoms.As a direct and proximate result, 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.The following additional information was received per the patient¿s implant records: the patient had a history of morbid obesity.The optease filter was positioned below the renal veins and above the iliac bifurcation.There was excellent hemostasis and the patient went to recovery room in stable condition.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately one-month post implantation.The patient reports tilting of the filter, blood clots, clotting and or occlusion of the inferior vena cava (ivc), ivc stenosis.The patient also reports experiencing physical pain and suffering as well as mental anguish, recurrent dvt, stenosis of the ivc, thrombolysis procedure and pain in the lower extremities related to clotting events as well as right lower quadrant pain.The patient further reports worrying about all the possible complications that the filter can cause, increased risk of filter strut migration, filter strut perforation of the ivc, filter strut perforation of internal organs and adjacent structures, filter fracture, bleeding pain and additional dvts, pulmonary embolism, post thrombotic syndrome and other serious complications, including death.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8408037
• MDR Text Key: 138386745
• Report Number: 1016427-2019-02610
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• 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: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR