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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466F220A
Device Problem Difficult to Remove (1528)
Patient Problems Coagulation Disorder (1779); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 01/01/2017
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 deep venous thrombosis (dvt) in the lower right extremity, a failed complex percutaneous retrieval attempt, and thrombus within 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. 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, deep vein thrombosis 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 filters are not indicated for use in the prevention of dvt. 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 deep venous thrombosis (dvt) in the lower right extremity, failed complex percutaneous retrieval attempt, thrombus within the filter and the resultant symptoms. Removal procedure details have not been provided. 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.
 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014 2802
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014 2802
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014-2802
7863138372
MDR Report Key12120376
MDR Text Key260467943
Report Number1016427-2021-05053
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2011
Device Catalogue Number466F220A
Device Lot NumberR1108433
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/27/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/06/2021 Patient Sequence Number: 1
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