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

Model Number 466FXXXX

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Occlusion (1984); Thrombosis (2100)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and the event date in the report is the awareness date.  as reported through the legal department via 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 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

Additional information received per the medical records indicate that the patient had a history of protein s deficiency, multiple deep vein thrombi, pulmonary emboli and the patient had a stroke (which resulted in weakness on her left side).The filter was deployed at the l1-l2 level, with no complications.According to the patient profile form (ppf) the filter was in place more than 90 days and too risky to attempt to retrieve.The patient experienced anxiety and panic.The patient is deceased.The date of death and cause of death were not provided.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly.It was reported that a patient underwent placement of an optease inferior vena cava (ivc) filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages; including, but not limited to blood clots, clotting and occlusion of the ivc filter, and recurrent deep vein thrombosis (dvt).The patient is reported to have experienced anxiety and panic.The information provided also indicated that the patient is deceased, the date of expiration and the cause of death has not been provided.The indication for the device implant was a history of deep vent thrombosis (dvt), pulmonary embolism (pe) in a patient with protein s deficiency.The patient also had a history of a stroke approximately twenty years prior to the implant.The patient had residual left upper and lower weakness as a result of the stroke.Approximately four months prior to the filter implant the patient presented with lower extremity dvt¿s and placed on lovenox and coumadin.The patient had never had a pulmonary evaluation of the pe¿s but continued to have them, as such the patient was sent for consideration of a ivc filter implant.The filter was placed via the right femoral vein and deployed at the level of l1-l2 with no reported complications.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 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.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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 occlusion within the filter do not represent a device malfunction.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.A cause of death has also not been provided, as such it is not possible to determine what factors may have contributed to the death.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: UNKNOWN OPTEASE INFERIOR VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; IC
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014
• MDR Report Key: 6508569
• MDR Text Key: 73333628
• Report Number: 1016427-2017-00267
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2018

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 Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/30/2017
• Date Manufacturer Received: 05/27/2018
• 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
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 67 YR