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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
Model Number 466F220A
Device Problems Occlusion Within Device (1423); Failure to Align (2522)
Patient Problem Thrombosis (2100)
Event Date 03/13/2017
Event Type  Injury  
Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date. As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter. The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: clot in the filter, filter tilt, and failed attempted removal. As a direct and proximate result, 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, pain, and suffering, and other damages. No additional information is available. 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. Without images, procedural films or medical records available for review, the reported events could not be confirmed and the exact cause could not be determined. Thrombosis within the ivc filter does not represent a device malfunction. Clinical factors that may have influenced this include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation of the filter. Additionally, the timing and mechanism of the reported filter tilt is unknown. Patient, technique or procedural factors may have contributed to the reported tilt. 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. Please note that this is the initial/final report for this product.

 
Event Description

As reported through the legal department via a legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter. The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: clot in the filter, filter tilt, and failed attempted removal. As a direct and proximate result, 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, pain, and suffering, and other damages. No additional information is available.

 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel co., tipperary 33152
EI 33152
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel co., tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key7662642
MDR Text Key113159056
Report Number1016427-2018-01617
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/04/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2016
Device MODEL Number466F220A
Device Catalogue Number466F220A
Device LOT Number16004156
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/12/2014
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: 07/04/2018 Patient Sequence Number: 1
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