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

Model Number 466FXXXX

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown.The event date listed is the awareness date.  as reported through the legal department via a legal brief, the plaintiff underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the plaintiff including, but not limited to, blood clots, clotting and occlusion of the ivc filter, and recurrent deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.No additional information is available.  the product was not returned for inspection.Manufacturing records (dhr) could not be performed as the product catalog and lot number were not available.  the cordis optease® vena cava filter (filter) is designed for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (ivc).The self-centering optease filter is laser cut from nickel titanium alloy (nitinol) tubing.The proximal and distal baskets of the optease filter, which consist of struts in a six diamond-shape configuration, are designed for optimal clot capture.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 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.Thrombus within the vessel (or in the filter) does not represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.The product¿s instructions for use indicates that filter obstruction and thrombus formation are potential complications of filter implantation.Dvts are distinguished as being above or below the popliteal vein.Very extensive dvts can extend into the iliac veins or the inferior vena cava.Dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of your lower leg (calf), and can spread up to the veins in your thigh.Dvt can also first develop in the deep veins in your thigh and, more rarely, in other deep veins, such as the ones in your arm.Deep vein thrombosis is the result of three principal factors:   reduced or stagnant blood flow in deep veins (venous stasis).   injury to the blood vessel wall.   an increase in the activity of those substances in the blood that are part of the normal clotting mechanism, a condition called hypercoagulability (which means a more active clotting state).Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt.Inferior vena cava filters are used to prevent sequelae, especially pe, in patients with contraindications to, complications of, or failure of anticoagulation therapy and patients with extensive free-floating thrombi or residual thrombi following massive pe.Placement of a vena cava filter reduces, but does not eliminate the risk of symptomatic pe in patients with proximal dvt in the short-term and does not prevent small pe.Factors that may have influenced the event include patient, pharmacological and lesion.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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 through the legal department via a legal brief, the plaintiff underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the plaintiff including, but not limited to, blood clots, clotting and occlusion of the ivc filter, and recurrent deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.No additional information is available.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for the implant was deep vein thrombosis (dvt), details not provided.The filter was placed via the right internal jugular vein during the index procedure and it was reported that the patient tolerated the procedure well; however, the medical notes indicate that a stat portable chest x-ray was performed to rule out any pneumothorax.It was reported that the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting and occlusion of the ivc filter, and recurrent deep vein thrombosis (dvt).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.Additional information contained in the patient profile form indicated that the patient experiences anxiety, slow mobility, blood clots to each leg, so is now using a cane and shortness of breath requiring the use of inhalers.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.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.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Blood clots and thrombosis within the filter do not represent a device malfunction.Without the procedural films or post-placement imaging and with the limited information provided, the report of thrombosis, blood clots, clotting and occlusion of the inferior vena cava (ivc) filter and recurrent dvt could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.Additionally, the timing and mechanism of the reported shortness of breath could not be determined with the limited information provided, nor can a clinical conclusion be made as to the cause of the event.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing in the reported information 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.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6507894
• MDR Text Key: 73327406
• Report Number: 1016427-2017-00266
• Device Sequence Number: 1
• Product Code: DTK
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15762761
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/29/2017
• Date Manufacturer Received: 12/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR