MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN OPTEASE FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466FXXXX

Device Problem Difficult to Remove (1528)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Stenosis (2263)

Event Date 11/11/2011

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages including, but not limited to failed removal and stenosis.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.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) 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.Permanent ivc filters have been reported to obstruct in up to 20% of patients.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.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: failed removal and stenosis.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b1, b3, b4, b5, b6, b7, d11, g1, g3, g4, g7, h1, h2 and h6.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, history includes acute dvt and noncompliance with anticoagulation, iv heroine abuse, cardiac arrest requiring cpr.After injection of heroin into the thigh, the patient presented with symptoms of dvt, and imaging confirmed deep vein thrombosis in the right lower extremity including the external iliac, femoral and popliteal veins.The filter was deployed via the patient's left common femoral vein.Significant resistance was encountered at the external iliac vein and stenosis in the left external iliac vein was noted.The stenosis of 70% was angioplastied with residual stenosis of 30%.Subsequently the filter was deployed distal to the bilateral renal veins.The patient tolerated the procedure very well.The filter subsequently malfunctioned and caused injury and damages including, but not limited to failed removal and stenosis.Per the patient profile form (ppf), the patient reports the device was unable to be retrieved, blood clots, clotting and or occlusion of the inferior vena cava (ivc).The patient has also reported swollen legs, difficulty breathing, can't stand for long periods of time, low stamina, inability to perform sexually, tremble in the hands and head, and fear.The patient states that he continues to experience low blood oxygen which has led to trouble thinking, difficulty breathing at night which leads to hung over feeling and unable to do physical work.The first failed removal attempt was two months after the index procedure and the second failed removal attempt was five months and two weeks after the index procedure.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.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) 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.Permanent ivc filters have been reported to obstruct in up to 20% of patients.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, sob, difficulty standing, and sexual dysfunction 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of acute deep vein thrombosis in the right iliofemoral veins and noncompliance with anticoagulation treatment medication.Two years prior to the index procedure the patient had an episode of cardiac arrest and required cardiopulmonary resuscitation (cpr).At that time the patient was advised to use coumadin; however, the patient admitted that he was noncompliant with the anticoagulation medicinal treatment.The patient presented to the emergency room (er) with acute extensive swelling in the right lower extremity.The patient was an intravenous (iv) heroin user and was injecting heroin into his right groin one day prior to his presentation.The patient noticed acute, severe swelling from the right foot up to the thigh with severe pain in the right groin and the medial thigh a day after iv use.The medical record states that the patient was not able to move his right lower extremity prior to presenting to the er.A diagnostic study showed the patient had deep vein thrombosis in the right lower extremity deep venous system including the external iliac vein, the femoral and popliteal veins.  the filter was deployed via the patient's left common femoral vein.The left external iliac vein was narrow and stenotic for a long segment in its entire length, but became normal diameter in the common iliac vein.There was reflux into the hypogastric vein.The cordis filter sheath was placed over the bentson wire and attempted to advance into the common iliac vein.Significant resistance was encountered at the external iliac vein and stenosis in the left external iliac vein appears to prevent advancement of the sheath into the common iliac vein.A dilator was used.After the dilator was removed a venogram was performed to identify the significant stenotic segments.The stenosis appeared to be greater than 70%.A balloon angioplasty was performed and the stenosis was still greater than 50%.Another balloon angioplasty was performed and the stenosis was close to 30%.The diameter was large enough to accommodate the inferior vena cava (ivc) filter sheath.Subsequently the pin-and-pull technique was used to successfully deploy the filter distal to the bilateral renal veins.The patient tolerated the procedure very well.  additional information received per the patient profile form (ppf) states that the device was unable to be retrieved, the patient experienced blood clots, clotting and or occlusion of the inferior vena cava (ivc).The patient has also experienced swollen legs due to "slow blood" from the filter, splotchy, swollen feet, difficulty breathing when active, can't stand for long periods of time, low stamina, inability to perform sexually, fear and meridian tremble in hands and head.The patient states that he continues to experience low blood oxygen which has led to trouble thinking, difficulty breathing at night which leads to hung over feeling and unable to do physical work.The ppf states that the first failed removal attempt was two months after the index procedure.The second failed removal attempt was five months and two weeks after the index procedure.

• Brand Name: UNKNOWN OPTEASE FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10252308
• MDR Text Key: 198910101
• Report Number: 1016427-2020-04166
• 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
• Report Date: 08/24/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 18 GAUGE ENTRY NEEDLE; UNKNOWN BOSTON WIRE; UNKNOWN J WIRE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 30 YR