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

Catalog Number 466FXXXX

Device Problems Fracture (1260); Difficult to Remove (1528); Unintended Movement (3026)

Patient Problems Coagulation Disorder (1779); Perforation (2001); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused tilting, perforation, fracture, embedment and thrombosis of the filter.The indication for the filter implant, procedural details and medical history of the patient have not been provided and there is currently no additional information available for review.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 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.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implant.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 for embedding with in the wall of the ivc is the development of endothelialization, 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The ifu states filter fracture with perforation is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Without images available for review the reported events could not be confirmed or further clarified.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 damage to the patient, including, but not limited to physical and emotional injuries and damages from tilting, perforation, fracture, embedment and thrombosis of the filter with resultant symptoms.As a direct and proximate result of this malfunction, the patient suffered 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.

Event Description

Per the implant records, the patient was reported to have a sudden respiratory decompensation, and a computed tomography angiography (cta) revealed pulmonary emboli.The patient was not a candidate for anticoagulation therapy due to a recent trauma, and the filter was indicated as prophylaxis against pulmonary embolism (pe).An ultrasound examination of the right inguinal area showed a widely patent right common femoral vein and a patent right common femoral artery.After sterile preparation and draping, using ultrasound guidance, the right common femoral vein was catheterized by percutaneous micropuncture seldinger technique.Using guidewire exchange technique, the optease retrievable filter was placed in the caudal portion of the inferior vena cava (ivc), and an angiogram was obtained, revealing the ivc to be of normal size and configuration.The optease filter was then successfully placed infrarenal.The patient tolerated the procedure well.A copy of a radiological image received for review appears to show an ivc filter; however, a radiological report was not provided.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc and thrombosis, becoming aware of these events about fourteen years after the filter was implanted.The patient further reports undergoing a percutaneous removal of the device about fourteen years and three months after implantation, and that the filter is fractured, retained and embedded in the wall of the ivc.Removal procedure details were not provided.The patient further asserts to requiring a significant hospital stay in the intensive care unit (icu) having procedures in interventional radiology (ir) to remove blood clots to restore circulation, which led to increased stress, anxiety and depression.Also, when the device was removed, a stent was placed in the ivc to restore proper blood flow; therefore, the patient is also worried about possible stent failure.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have recently sustained a trauma and subsequently developed sudden respiratory decompensation.Diagnostic testing revealed pulmonary emboli (pe).The indication for the filter placement was reported to be as prophylaxis against further pe in a patient who was not a candidate for anticoagulation therapy.The filter was implanted via the right common femoral vein and placed in an infrarenal position.The patient is reported to have tolerated the procedure well.More than fourteen years after the filter implantation, the patient became aware that the filter had tilted, fractured and become embedded in the wall of the inferior vena cava (ivc).Filter struts had perforated outside the ivc.In addition, the patient reported thrombosis of the filter.Approximately fourteen years and three months after the filter implantation, the patient underwent successful percutaneous retrieval of the filter with the placement of a stent in the ivc to restore blood flow.A filter fragment was reported to have been retained in the caval wall.Details of this procedure were not provided.The patient also reported having had a significant hospital stay in the intensive care unit and having undergone procedures to remove blood clots and restore circulation.The details of this hospital stay and of the procedures were not provided.The patient further reported having experienced stress, anxiety and depression associated with the filter.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.Without images or procedural films for review, the reported filter tilt, fracture, retrieval difficulty and ivc 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.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.The reported details indicate that retrieval was attempted more than fourteen years after implantation.Retrieval of the optease retrievable vena cava filter is indicated up to 23 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 twelve days.It is unknown if the tilt contributed to the reported perforation.A review of the 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.Clotting and/or thrombosis within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological 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: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 12049067
• MDR Text Key: 257744156
• Report Number: 1016427-2021-05016
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• 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: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK GUIDEWIRE.; UNKNOWN.
• Patient Outcome(s): Life Threatening
• Patient Age: 31 YR