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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466FXXXX
Device Problems Fracture (1260); Difficult to Remove (1528)
Patient Problem Perforation of Vessels (2135)
Event Date 08/02/2017
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 a patient underwent placement of an optease vena cava filter. The information provided indicated that the filter subsequently malfunctioned and caused injury and damage to the patient. Approximately eleven years post implant a computerized tomography scan (ct) of the abdomen and pelvis was performed and indicated the optease filter was present, no injury was noted. Approximately two weeks after the ct scan the patient underwent a complex percutaneous retrieval via the right common femoral and right internal jugular. During the procedure it was noted that the struts were projected outside the inferior vena cava (ivc). A loop wire technique was used to snare the filter, resulting in fracturing the filter and only being able to remove part of the filter. The doctor attempted, unsuccessfully, to remove the remaining parts via the right internal jugular. Two stents were inserted. The stents were crushing the filter fragments against the walls of the ivc. Besides the fragments contained by the stents, there was a single strut embedded in the cava wall which remained after multiple attempts to retrieve it. 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. The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation. Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts. Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling. 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 also states that 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. As indicated, the filter fracture most likely occurred during the complex retrieval attempt. 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 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. As a direct and proximate result of these malfunctions, the patient suffered bodily injury and resulting in pain and suffering, disability, mental anguish, loss of capacity for enjoyment of life, expense of hospitalization, medical and nursing care and treatment, and will require ongoing medical care and monitoring for the rest of her life. The patient¿s injuries are permanent and continuing and she will suffer such losses in the future. Approximately eleven years after the index procedure the patient underwent a computerized tomography scan (ct) of her abdomen and pelvis that indicated the optease filter was present, no injury was noted approximately two weeks after the ct scan the patient underwent a complex percutaneous retrieval via the right common femoral and right internal jugular. During the procedure it was noted that the struts were projected outside the inferior vena cava (ivc). A loop wire technique was used to snare the filter, resulting in fracturing the filter and only being able to remove part of the filter. The doctor attempted, unsuccessfully, to remove the remaining parts via the right internal jugular. Two stents were inserted. The stents were crushing the filter fragments against the walls of the ivc. Besides the fragments contained by the stents, there was a single strut embedded in the cava wall which remained after multiple attempts to retrieve it.

 
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Brand NameUNKNOWN OPTEASE VENA CAVA FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key12381692
MDR Text Key268664947
Report Number1016427-2021-05349
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466FXXXX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/30/2021 Patient Sequence Number: 1
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