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

Catalog Number 466F220A

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

Patient Problems Embolus (1830); Occlusion (1984); Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263)

Event Date 06/20/2019

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, damage to the patient, including but not limited to blood clots, caval stenosis and caval thrombosis.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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.  if obtained, a follow up report will be submitted within 30 days upon receipt.

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, damage to the patient, including but not limited to blood clots, caval stenosis and caval thrombosis.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering, and other damages.

Event Description

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis and an aversion to anticoagulation therapy.The filter was deployed via the patient's right femoral vein.The filter was placed below the renal veins and above the common iliac vein bifurcation.There were no complications during the procedure.  additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting and or occlusion of the inferior vena cava (ivc).The patient became aware of the reported events approximately twelve years and four months after the index procedure.The form states that the device was unable to be retrieved and it also states that there have been no attempts to remove the device.The patient reported anxiety, 'worsening loss of circulation and mobility to lower extremities below the ivc filter.'.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a1, a2, a4, b3, b4, b5, b7, d1, d3, d11, g3, g4, g7, h1, h2 and h6.As reported, the patient had placement of an optease inferior vena cava (ivc) filter.Per the medical records, the indication was deep vein thrombosis with non-compliance to anticoagulation.The filter was deployed below the renal veins and above the iliac vein bifurcation.There were no reported complications.The filter subsequently malfunctioned including blood clots, caval stenosis and thrombosis.Per the patient profile form (ppf), the patient reports blood clots, clotting and or occlusion of the ivc, and anxiety, loss of circulation and mobility of the lower extremities.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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.Anxiety, loss of circulation and mobility 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

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury, damage to the patient, including but not limited to blood clots, caval stenosis and caval thrombosis.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis (dvt) and aversion to anticoagulation therapy.The filter was deployed via the patient's right femoral vein.The filter was placed below the renal veins and above the common iliac vein bifurcation.There were no complications during the procedure.  additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting and or occlusion of the inferior vena cava (ivc).The patient became aware of the reported events approximately twelve years and four months after the index procedure.The form states that the device was unable to be retrieved and it also states that there have been no attempts to remove the device.The patient reported anxiety, 'worsening loss of circulation and mobility to lower extremities below the ivc filter.Per the redacted amended ppf, the patient additionally reports perforation of filter struts outside the ivc, perforation of filter struts into organs and filter tilting, becoming aware of these events approximately twelve years and four months after implantation.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of deep vein thrombosis (dvt) and was unable to take anticoagulation therapy.The indication for the filter placement was not reported.The filter was implanted via the right femoral vein and placed in an infrarenal position above the common iliac vein bifurcation without complications.More than twelve years after the filter implantation, the patient became aware that the filter had tilted, and that filter strut(s) had perforated outside the wall of the inferior vena cava (ivc) and into organs.The filter was also associated with caval stenosis, caval thrombosis, blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The patient also indicated that the filter was irretrievable.Provided documentation indicates that retrieval of the device was not attempted.The patient further reported having experienced anxiety and worsening circulation and mobility to the lower extremities associated with the filter.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (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.Without images or procedural films for review, the reported filter tilt and ivc and organ perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforations.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Stenosis, blood clots, clotting, embolism, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported circulatory insufficiency and decreased mobility experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10440471
• MDR Text Key: 204001809
• Report Number: 1016427-2020-04304
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466F220A
• Device Lot Number: R0906250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPTEASE 6 FRENCH SHEATH; UNKNOWN FRENCH DILATOR; UNKNOWN GUIDE WIRE; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 73 YR
• Patient Weight: 100