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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
Catalog Number 466FXXXX
Device Problems Filter (816); Fracture (1260); Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100)
Event Date 04/15/2016
Event Type  Injury  
Manufacturer Narrative

Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported by the legal brief, the patient underwent placement of an optease permanent vena cava filter. The following additional information received per the patient profile form indicates that seven years and ten months post implantation the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc). The patient reports that the filter has lodged and suffers from depression. According to the medical records, the patient has a history of deep vein thrombosis (dvt) and pulmonary embolism (pe). The filter was successfully deployed during the index procedure without complications.

 
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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
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7057981
MDR Text Key92902627
Report Number9616099-2017-01620
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK034050
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,Followup,Followup
Report Date 07/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466FXXXX
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 Received07/15/2018
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: 11/24/2017 Patient Sequence Number: 1
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