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

Model Number 466F220A

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

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.(b)(4).Additional information is pending and will be submitted within 30 days of receipt.Please note that this is the initial report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of an 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 perforation and ivc stenosis.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, pain and suffering, and other damages.Additional information received per the medical records indicate that the patient has a history of t3 fracture, multiple blunt trauma and right below the knee amputation.The filter was deployed via the patient's right common femoral vein.It was placed into the infrarenal area.The patient tolerated the procedure well.There were no apparent complications and no apparent tilt. additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside the inferior vena cava (ivc), perforation of filter struts into organs, deep vein thrombosis (dvt), stenosis and caval thrombosis.The patient became aware of the reported events approximately eight years and six months after the index procedure.The patient has also experienced left plank pain and anxiety.

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 perforation and inferior vena cava (ivc) stenosis.The patient reported becoming aware of perforation of filter struts outside the ivc, perforation of filter struts into organs, deep vein thrombosis (dvt), stenosis and caval thrombosis, approximately eight years and six months post implant.The patient also reported experiencing left flank pain and anxiety.According to the medical record, the indication for the filter implant was multiple blunt trauma, including t3 fracture and right below the knee amputation, requiring multiple return trips to surgery and as a result cannot be adequately anticoagulated.The filter was placed via the right common femoral vein and deployed in the infrarenal ivc.The patient tolerated the procedure well with no apparent complications and no apparent tilt.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 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.Blood clots, clotting, stenosis and occlusive thrombosis and/or occlusion within the filter and vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Stenosis is an abnormal narrowing in a blood vessel.Ivc filters are not indicated for use in the prevention of dvt¿s.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.Without images available for review the reported events could not be confirmed or further clarified.Due to the nature of the complaint the reported flank pain could not be further clarified.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.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.

• 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: 11704643
• MDR Text Key: 261485680
• Report Number: 1016427-2021-04916
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• 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
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: 15526913
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 05/03/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6-FRENCH SHEATH; UNKNOWN BENTSON GUIDE WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 81 YR