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

Catalog Number 466F220A

Device Problems Difficult to Remove (1528); Failure to Align (2522); Migration (4003)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Obstruction/Occlusion (2422)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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 filter migration, filter tilt, filter embedment, and the filter is unable to be removed.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.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.Without images or procedural films for review, the reported filter tilt and migration could not be confirmed, nor a cause determined.Ivc filter tilt has been associated with practitioner technique, the anatomy of the vessel, specifically asymmetry and tortuosity.Ivc filter migration is a known potential adverse event associated ivc filters and is listed in the ifu as such.Possible causes for migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.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.Please note that this is the initial 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 filter migration, filter tilt, filter embedment, and filter is 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.

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 filter migration, filter tilt, filter embedment, and the filter is unable to be removed.There has been no documented attempt to retrieve the filter provided.The patient reported becoming aware of migration of entire filter other than to heart, filter tilt, filter embedded in wall of the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the ivc, approximately seven years and six months post implant.The patient also report anxiety related to the filter.According to the implant record the indication for the filter implant was a history of recurrent deep vein thrombosis (dvt) and multiple recurrent pulmonary emboli while on anticoagulation.The filter was placed via the right femoral vein and deployed below the lowest renal vein.A venography was performed which showed that the filter was in a satisfactory position.The patient was in stable condition and there were no complications.There is currently no additional information available for review.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 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, 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, clotting and/or occlusive thrombosis within the filter and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Without images or procedural films for review, the reported filter tilt and migration could not be confirmed, nor a cause determined.Ivc filter tilt has been associated with practitioner technique, the anatomy of the vessel, specifically asymmetry and tortuosity.Ivc filter migration is a known potential adverse event associated ivc filters and is listed in the ifu as such.Possible causes for migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Anxiety 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis and multiple recurrent pulmonary emboli while on anticoagulation therapy.The filter was deployed via the patient's right femoral vein using ultrasound guidance.The filter was placed below the lowest renal vein.A venography was performed which showed that the filter was in a satisfactory position.The patient was in stable condition and there were no complications.Additional information received per the patient profile form (ppf) states that the patient experienced migration of entire filter other than to heart, filter tilt, filter embedded in wall of the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the ivc.The patient continues to worry and has anxiety related to the filter.The patient became aware of the reported events approximately seven years and six months after the index procedure.The form states the device is unable to be retrieved, but it also states that there has been no attempt to remove the device.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10480764
• MDR Text Key: 205279218
• Report Number: 1016427-2020-04333
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Catalogue Number: 466F220A
• Device Lot Number: 15454044
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 GUIDEWIRE; UNKNOWN 6-FRENCH SHEATH; UNKNOWN MICRO ACCESS SHEATH AND DILATOR; UNKNOWN MICRO WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 38 YR