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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problem Difficult to Remove (1528)
Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Edema (1820); Occlusion (1984); Pain (1994); Swelling (2091); Thrombosis (2100); Vascular System (Circulation), Impaired (2572); No Code Available (3191)
Event Date 08/07/2012
Event Type  Injury  
Manufacturer Narrative
As reported by the legal team, the patient underwent placement of the optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting, and occlusion of the ivc, pe, thrombus within the filter and extending above the device, and failed retrieval attempt. 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. The product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record review could not be performed. The optease 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. Blood clots and occlusion of the ivc filter does not represent a device malfunction. Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such. There are possible patient and pharmacological factors that may have contributed to the reported event. The implantation date of the filter and the attempted retrieval date is unknown at this time. Retrieval of the optease vena cava filter is indicated up to 23 days post implantation. 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 is the development of endothelialization, which would make subsequent removal difficult. Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days. Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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 by the legal team, the patient underwent placement of the optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting, and occlusion of the ivc, pe, thrombus within the filter and extending above the device, and failed retrieval attempt. 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.
 
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Brand Name466FXXXX
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6977895
MDR Text Key90280304
Report Number1016427-2017-00710
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date10/09/2017
Event Location No Information
Date Manufacturer Received04/27/2018
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/25/2017 Patient Sequence Number: 1
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