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

Model Number 466FXXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Coagulation Disorder (1779); Dyspnea (1816); Nausea (1970); Occlusion (1984); Swelling (2091); Thrombosis (2100); Anxiety (2328)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

The product remains implanted and is thus not available for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Additional information is pending and will be submitted within 30 days upon receipt.

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 blood clots, clotting, and/or occlusion of the ivc and inability to retrieve the filter (unknown retrieval attempt was made).The following additional information received per the medical records indicate that the patient underwent placement of an 6fr optease vena cava filter via the right femoral vein for a massive pulmonary embolus.Approximately six years later, the patient was diagnosed with an occluded ivc filter and bilateral deep vein thrombosis.The patient was not on chronic anticoagulation at that time.The patient was later discharged on coumadin.Approximately two years later, the patient reported extreme heaviness and ¿bursting pressure¿ in his legs, shortness of breath and nausea when walking short distances.The patient was noted to have acute on chronic embolism and thrombosis of the ivc, saddle embolus of the pulmonary artery (without acute cor pulmonale) and bilateral lower extremity edema.The ivc occlusion extended from just below the renal veins, through the ivc filter and to the common femoral veins.The patient was deemed to be a poor surgical candidate and underwent caval and iliac venography with recanalization and stenting (24x45mm boston scientific wallstent) of a chronically occluded vena cava.In addition, recanalization and stenting of chronically occluded right (3 wallstents placed) and left (4 wallstents placed) common and external iliac veins.According to the information received in the patient profile from (ppf), the patient is reported to have experienced blood clots, clotting, and/or occlusion of the ivc, embedment of the filter in the wall of the ivc and an inability to retrieve the device (filter removal was not attempted).The patient is reported to have become aware of the alleged filter failure in the late spring of 2016.Additionally, the patient suffers from severe pain and swelling from blood clots in both legs.As a result, the patient is reported to be confined to a wheelchair.The patient underwent stent placement due to the occlusion of the filter.Furthermore, the patient suffers from mental anguish regarding the current status of the filter, stents and any additional injury that may be caused as a result of the filter.Because the filter remains implanted, the patient will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

Additional information was received from an updated patient profile form that the patient has deep vein thrombosis in both legs, severe swelling in legs that confine him to a wheel chair.The filter was occluded and left in the ivc.Stents were put in to cover the filter.The patient also reported that the filter caused clots in the right leg that are permanent and painful.The stents are monitored periodically to ensure they are working.As reported, the patient underwent placement of the optease inferior vena cava (ivc) filter.Per the medical records, the patient underwent filter placement for a massive pulmonary embolus.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to blood clots, clotting, and/or occlusion of the ivc and inability to retrieve the filter (unknown retrieval attempt was made).Approximately six years later, the was admitted for filter occlusion and bilateral deep vein thrombosis.The patient was not on anticoagulation; however, was discharged on coumadin.Approximately two years later, the patient reported extreme heaviness and ¿bursting pressure¿ in his legs, shortness of breath and nausea when walking.There was acute on chronic embolism and thrombosis of the ivc, saddle embolus of the pulmonary artery (without acute cor pulmonale) and bilateral lower extremity edema.The ivc occlusion extended from just below the renal veins, through the ivc filter and to the common femoral veins.The patient was deemed to be a poor surgical candidate and underwent caval and iliac venography with recanalization and stenting (24x45mm boston scientific wallstent) of a chronically occluded vena cava.In addition, recanalization and stenting of chronically occluded right (3 wallstents placed) and left (4 wallstents placed) common and external iliac veins.Per the patient profile from (ppf), the patient is reported to have experienced blood clots, clotting, and/or occlusion of the ivc, embedment of the filter in the wall of the ivc and an inability to retrieve the device (filter removal was not attempted).The patient suffers from severe pain and swelling in both legs and is confined to a wheelchair.The patient underwent stent placement due to the occlusion of the filter.Furthermore, the patient suffers from mental anguish.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 embolism, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, swelling of the legs, shortness of breath, and nausea do not represent a device malfunction and may be related to underlying patient related issues.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.

Manufacturer Narrative

As reported by the legal department, the patient underwent placement of the optease vena cava filter.Per the medical records, the patient had implant of the filter for a massive pulmonary embolus.The patient presented with chest pain that was later diagnosed as pulmonary embolism.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to blood clots, clotting, and/or occlusion of the ivc and inability to retrieve the filter (unknown retrieval attempt was made).Approximately 4 months later, the patient underwent cystoscopy with urethrotomy for urethral stricture (after unsuccessful outpatient dilatation).Approximately six years later, the patient was diagnosed with an occluded ivc filter and bilateral deep vein thrombosis.The patient was not on anticoagulation at that time, coumadin was started.Approximately eight years after implant, the patient reported extreme heaviness and ¿bursting pressure¿ in his legs, shortness of breath and nausea when walking short distances.The patient was noted to have acute on chronic embolism and thrombosis of the ivc, saddle embolus of the pulmonary artery (without acute cor pulmonale) and bilateral lower extremity edema.The ivc occlusion extended from just below the renal veins, through the ivc filter and to the common femoral veins.The patient was deemed to be a poor surgical candidate and underwent caval and iliac venography with recanalization and stenting of a chronically occluded vena cava, common and external iliac veins.Per the patient profile from (ppf), the patient reported blood clots, clotting, and/or occlusion of the ivc, embedment of the filter in the wall of the ivc and an inability to retrieve the device (filter removal was not attempted), severe swelling in legs that confine him to a wheel chair.Additionally, the patient suffers from severe pain and swelling from blood clots in both legs with stent placement.The filter was occluded and left in the ivc.Stents were put in to cover the filter.The patient also reported that the filter caused clots in the right leg that are permanent and painful.The patient reports mental anguish.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 embolism, dvt, and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, swelling of the legs, shortness of breath, and nausea do not represent a device malfunction and may be related to underlying patient related issues.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.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 00000 ; EI 00000
• MDR Report Key: 8109934
• MDR Text Key: 128567439
• Report Number: 1016427-2018-02319
• 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,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 12/06/2018; 01/10/2019
• Supplement Dates FDA Received: 01/03/2019; 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 72 YR
• Patient Weight: 154