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U.S. Department of Health and Human Services

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

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CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466F220A
Device Problems Fracture (1260); Difficult to Remove (1528); Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); No Code Available (3191)
Event Date 03/19/2012
Event Type  Injury  
Manufacturer Narrative

It was reported that a patient underwent placement of a optease vena cava filter. The provided indicated that the filter subsequently malfunctioned, including, but not limited to, perforation, and caused injury and damages to the patient. The information provided also indicated that as a direct and proximate result of these malfunctions, the patient suffered life- threatening injuries and damages, and required extensive medical care and treatment and as a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. There is currently no additional information available. 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. 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 complications related to ivc filters. 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 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. 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. With the limited information available and without the procedural films or post implant images to review the reported device perforation of the inferior vena cava could not be confirmed. Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics. 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 by the legal brief, the patient underwent placement of defendants' optease vena cava filter. The filter subsequently malfunctioned, including, but not limited to, perforation, and caused injury and damages to the patient. 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 NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7392346
MDR Text Key104176286
Report Number1016427-2018-01344
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2014
Device Catalogue Number466F220A
Device LOT Number15454044
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 Received05/04/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/31/2010
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: 04/03/2018 Patient Sequence Number: 1
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