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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Blood Loss (2597)
Event Date 11/21/2019
Event Type  Injury  
Manufacturer Narrative

The exact implant date is unknown; stated as 2015. The catalog number is unknown, if received it will be provided. Complaint conclusion: 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 caval thrombosis and deep vein thrombosis (dvt). The indication for the filter implant was not 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. Blood clots, clotting and/or occlusive thrombosis or occlusion within the filter and/or the vasculature do not represent a device malfunction. Ivc filters are not indicated for use in the prevention of dvt. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. With the limited information provided the reported event(s) could not be confirmed or further clarified. 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.

 
Event Description

As reported by the legal brief, the patient underwent placement of a optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages including, but not limited to: dvt, caval thrombosis. As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, 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, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cashir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9298081
MDR Text Key167137229
Report Number1016427-2019-03530
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,Followup
Report Date 02/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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?
Event Location No Information
Date Manufacturer Received01/21/2020
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? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/08/2019 Patient Sequence Number: 1
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