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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 Problem Difficult to Remove (1528)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Swelling (2091); Thrombosis (2100); Stenosis (2263)
Event Date 01/01/2019
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, the patient underwent placement of an optease inferior vena cava (ivc) filter. The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to deep vein thrombosis (dvt), filter is embedded and unable to be removed. The filter remains implanted; thus, unavailable for analysis. No attempt to remove the device has been documented. 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. Endothelialization is the 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. Dvt does not represent a device malfunction. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Without procedural films or images for review the reported event(s) could not be confirmed. 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/final 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 deep vein thrombosis (dvt), filter is embedded and 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. Although the brief states that the filter was unable to be retrieved, no attempt to remove the device has been documented.
 
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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 33152
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33152
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9861686
MDR Text Key188517832
Report Number1016427-2020-03953
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number466FXXXX
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 Received04/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/20/2020 Patient Sequence Number: 1
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