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

Catalog Number 466FXXXX

Device Problem Unintended Movement (3026)

Patient Problems Device Embedded In Tissue or Plaque (3165); Unspecified Tissue Injury (4559)

Event Date 08/06/2019

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 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 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.Post implant imaging has not been provided.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt could not be confirmed or further clarified.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with operator technique, vessel characteristics, specifically asymmetry and tortuosity.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.

Event Description

As reported in the legal brief, a 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 damages from tilting of the filter 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 patient presented to hospital with complaints of back pain and chest discomfort.Diagnostic testing revealed right lower lobe pulmonary embolism (pe), elevated liver function tests and lower extremity deep vein thrombosis (dvt).Further testing revealed that the patient had previously undergone cholecystectomy and had a prominent common bile duct.The patient underwent endoscopic retrograde cholangiopancreatography (ercp) for choledocholithiasis, and a stone was seen fluoroscopically.The patient¿s anticoagulation therapy was held in anticipation of a possible mild sphincterotomy.The indication for the filter placement was reported to be for the dvt with a current contraindication 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 and without complications.More than eleven years after the filter implantation, the patient became aware that the filter had tilted and become embedded within the inferior vena cava (ivc).No documented evidence of a retrieval attempt was provided.The patient further reported having experienced anxiety 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 and device embedment 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 predominant concern for embedding within the wall of the ivc is the development of endothelialization.Endothelialization is 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.The optease retrievable vena cava filter is indicated for retrieval up to 23 days post-implantation.Following this period of time, and as early as twelve days, there is potential for endothelialization 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 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.

Event Description

As reported in the legal brief, a 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 damages from tilting of the filter 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.According to the medical records, three days prior to the index procedure, the patient presented to the emergency department with complaints of back pain and chest discomfort and was found to have pulmonary embolism (pe) and deep vein thrombosis (dvt) of the lower extremity.Ultrasound of the abdomen on admission demonstrated status post cholecystectomy with prominent common bile duct.The patient underwent an endoscopic retrograde cholangiopancreatography (ercp) for choledocholithiasis, and a stone was seen fluoroscopically.Because of the need for a possible mild sphincterotomy to remove the stone from the common bile duct, the patent¿s coumadin and lovenox were held.At that point, the inferior vena cava (ivc) filter was placed.Per the implant records, the filter was indicated for dvt with transient contraindication to anticoagulation.The right common femoral vein was accessed under direct ultrasound guidance.A femoral and iliac venogram showed patency of the inferior vena cava, and a sheath was then advanced into the inferior vena cava.An inferior vena cavagram showed patency of the right atrium and clear delineation of the renal vein inflow.The optease ivc filter was deployed infrarenal.According to the information received in the patient profile form (ppf), the patient reports tilting, and filter embedded in wall of the inferior vena cava (ivc), becoming aware of these events approximately eleven years and four months after the filter implantation, and further experienced anxiety related to the filter.

• 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: 12121061
• MDR Text Key: 260467146
• Report Number: 1016427-2021-05054
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 6F SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 42 YR