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

Model Number 466F220A

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

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 09/10/2020

Event Type  Injury  

Event Description

As reported in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused physical and emotional damages from recurrent deep vein thrombosis (dvt), inferior vena cava (ivc) stenosis and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter was associated with recurrent deep vein thrombosis (dvt) and stenosis of the inferior vena cava (ivc).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 retrievable 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.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.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.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.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 in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused physical and emotional damages from recurrent deep vein thrombosis (dvt), inferior vena cava (ivc) stenosis and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.The following additional information was received per the patient¿s medical records: the patient has a history of coronary artery disease and pulmonary embolus.The filter was implanted via the right femoral vein in the infrarenal inferior vena cava.The patient tolerated the procedure well with no apparent complications.The patient had subsequently had recurrent episodes of venous thromboembolism with multiple procedures including thrombolysis and thrombectomy; therefore, the filter was removed percutaneously approximately 10 years and 11 months post implantation.During the removal procedure, an intact intra-filter thrombus was noted to occupy 25% of the volume of the filter.Inferior fibrin sheaths were positioned adjacent to the inferior and superior aspects of the filter.A wire loop was attempted to be performed to engage the inferior aspect of the filter with a catheter and glidewire.This was unsuccessful due to the fibrin cap noted on venography.Endobronchial forceps were then advanced and used to dissect out the inferior apex.The inferior apex was engaged with forceps and pulled into the 16f sheath.A wire loop was then formed from above using a catheter and glidewire to engage the superior aspect of the filter.The glidewire was then snared and the loop glidewire was used to pull the most superior portion of the filter apex in the to the 16f sheath.The inferior 18f sheath was exchanged for a 16f sheath with a purse string suture about the smaller sheath to maintain hemostasis; the sheath was exchanged for necessary length to facilitate capture of the embedded filter.Simultaneous traction and sheath advancement both from above and below was only partially able to collapse the filter.The traction resulted in fracture of the superior wire loop requiring re-formation.Further dissection was performed with the endobronchial forceps from below to further free the device.Ultimately an excimer laser was advanced from above through the 16f sheath over the wire loop (exchange length glidewire).The filter was slowly removed from the ivc with slow advancement of the laser and increased energy.The filter was then reengaged with both superior and inferior sheaths with complete collapse using simultaneous traction from both above and below.The filter was then removed intact through the superior sheath.During the same removal procedure, the patient had persistent infrarenal ivc stenosis requiring angioplasty.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 10 years and 9 months post implantation.The patient reports blood clots, clotting, and/or occlusion of the ivc.The filter was successfully removed percutaneously approximately 10 years and 11 months post implantation.The patient also reports suffering from severe pain in the area where the ivc filter was previously implanted.

Manufacturer Narrative

Additional information was provided and is available in: section a2 (age at the time of event, date of birth) section b3 (event date) section b4 (event description) section d1 (brand name) section d4 (model, catalog, lot number, expiration date) section g4 (date received by the manufacturer and pma/510(k) number) section h4 (manufacturing date) section h6 (evaluation codes) 1528- difficult to remove 3191 - thromboembolism 1779 ¿ coagulopathy/clotting complaint conclusion: as reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused recurrent deep vein thrombosis (dvt) and inferior vena cava (ivc) stenosis.The patient reported becoming aware of blood clots, clotting, and/or occlusion of the ivc approximately 10 years and 9 months post implant.The filter was successfully removed percutaneously approximately 10 years and 11 months post implant.The patient also reports severe pain in the area where the ivc filter was previously implanted.According to the medical records had a history of multiple medical problems including coronary artery disease and pulmonary embolus (pe) in the past.The indication for the filter implant was recurrent pe.The filter was placed via the right femoral vein and deployed in the ivc.A repeat venogram showed adequate position of the ivc filter below the renal veins.The patient tolerated the procedure well with no apparent complications.According to the ivc retrieval report, the patient had recurrent episodes of venous thromboembolism with multiple procedures including thrombolysis and thrombectomy; therefore, it was decided to remove the filter.The patient underwent a complex percutaneous removal procedure approximately 10 years and 11 months post implant.Via access from the right internal jugular and right common femoral veins, successful laser and forceps assisted retrieval of the infrarenal ivc filter was performed.Biopsy forceps were used to dissect the fibrin cap at the inferior apex of the filter during the procedure.While performing simultaneous traction and sheath advancement both from above and below was only partially able to collapse the filter.The traction resulted in fracture of the superior wire loop requiring re-formation.Further dissection was performed with the endobronchial forceps from below to further free the device.Ultimately an excimer laser was advanced from above through the 16f sheath over the wire loop (exchange length glidewire).The filter was slowly removed from the ivc with slow advancement of the laser and increased energy.The filter was then reengaged with both superior and inferior sheaths with complete collapse using simultaneous traction from both above and below.The filter was then removed intact through the superior sheath.During the same removal procedure, the patient had persistent infrarenal ivc stenosis requiring angioplasty.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 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.Blood clots, clotting and/or occlusion of the filter and/or the vasculature and stenosis do not represent a device malfunction.Stenosis is an abnormal narrowing in a blood vessel and does not represent a device malfunction but is most likely related to patient factors and/or vessel characteristics.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Clinical factors that may have influenced these events include patient, pharmacological and vessel characteristics.Inferior vena cava filters are not indicated for use in the prevention of deep vein thrombosis.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.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 instructions for use (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 explant problems after as short a period as 12 days.Pain 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
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 12656689
• MDR Text Key: 281131360
• Report Number: 9616099-2021-04950
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: R1108432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2008
• 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): Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male