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

Catalog Number 466FXXXX

Device Problem Difficult to Remove (1528)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Swelling (2091); Thrombosis (2100); Stenosis (2263)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to deep vein thrombosis (dvt), filter is embedded and unable to be removed.The filter remains implanted; thus, unavailable for analysis.No attempt to remove the device has been documented.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Dvt does not represent a device malfunction.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 this is the initial/final report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of a optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to deep vein thrombosis (dvt), filter is embedded and unable to be removed.As a direct and proximate result of these malfunctions, 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 continue to suffer significant medical expenses, and pain and suffering, and other damages.Although the brief states that the filter was unable to be retrieved, no attempt to remove the device has been documented.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, a4, b1, b3, b4, b5, b7, 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, history includes chronic dvt with leg swelling.The filter was implanted secondary to a bleeding ulcer with inability to anticoagulate.The exact implant date is unknown; however, it was reported that filter has been in place (b)(4) - (b)(4) years.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to deep vein thrombosis (dvt).Per the patient profile form (ppf), the patient reports the device unable to be retrieved, blood clots, clotting, and/or occlusion of the ivc.The patient continues to experience leg swelling, emotional distress, mental anguish, anxiety, stress, shortness of breath and the patient is unable to walk long distances.Approximately (b)(4) ¿ (b)(4) post implant, the patient had shoulder surgery complicated by pulmonary embolism.Approximately (b)(4) years post implant, an unsuccessful percutaneous filter removal attempt was done.The physician was unable to access the inferior vena cava secondary to severe scarring, stenosis and occlusion of the ivc.Endovascular surgery was recommended for removal of the filter and reconstruction of the ivc.Three months later the patient had leg edema, pain, immobility and shortness of breath.The following week, a successful recanalization of the ivc and left iliac vein using balloon angioplasty and stent placement was done.The right iliac vein remained occluded.The patient was discharged and was noted to have a decrease in pain and swelling of the legs with an increasing tolerance for ambulation.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 and scarring of the ivc and iliac veins is associated with all ivc filter products and does not represent a device malfunction.A protective 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.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 (b)(4) days.Post procedural pulmonary embolism is a known potential event associated with the filter device, patent specific issues, specifically the underlying causes of thrombus formation, may contribute to these events.Leg swelling, pain, anxiety, shortness of breath, and walking difficulty 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 patient profile form (ppf) states that the patient experienced filter embedment in wall of the inferior vena cava (ivc), device unable to be retrieved, blood clots, clotting, and/or occlusion of the ivc.The patient continues to experience leg swelling, emotional distress, mental anguish, anxiety, stress, shortness of breath and the patient is unable to walk long distances.Additional information received per the medical records indicate that the patient has a history of chronic deep vein thrombosis (dvt) with leg swelling.The filter was implanted secondary to a bleeding ulcer. the implant date is unknown.The filter was stated to have been in place sixteen to eighteen years.Fourteen to sixteen years after the index procedure the patient had shoulder surgery and experienced pulmonary embolism.At least fifteen years after the index procedure there was an unsuccessful percutneous filter removal attempt.The physician was unable to access the inferior vena cava secondary to severe scarring, stenosis and occlusion of the ivc.Endovascular surgery was recommended for removal of the filter and reconstruction of the ivc.Three months later the patient experienced leg edema, pain, immobility and shortness of breath.An intervention was planned.The following week the patient had a successful recanalization of the ivc and left iliac vein using balloon angioplasty and stent placement was done.The right iliac vein remained occluded.The patient was discharged and was noted to have a decrease in pain and swelling of the legs with an increasing tolerance for ambulation.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33152
• MDR Report Key: 9861686
• MDR Text Key: 188517832
• Report Number: 1016427-2020-03953
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• 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
• Date Manufacturer Received: 04/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR
• Patient Weight: 129