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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 Filter (816); Occlusion Within Device (1423); Defective Component (2292)
Patient Problems Occlusion (1984); Thrombosis (2100)
Event Date 08/01/2016
Event Type  Injury  
Manufacturer Narrative

A review of the manufacturing documentation associated with this lot (16066554) presented no issues during the manufacturing process that can be related to the reported event. This report is a follow up report to mfr number 9616099-2016-00502 that was submitted under the previous complaint handling software system. The information has been duplicated from the first report with additional information added. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported by the legal brief, the patient had an optease inferior vena cava (ivc) filter implanted. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter collapsed with extensive blood clots below and above the filter. 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 following additional information received per the patient profile form indicates that the patient had clotting and/or occlusion of the ivc and that the device was unable to be retrieved although there is no record of the patient undergoing a removal attempt. The patient reports to be suffering from occasional pain, emotional distress, loss of libido and sensation. According to the medical records, the patient suffered from deep vein thrombosis prior to the filter implantation. The filter was successfully deployed below the renal veins. The patient tolerated the index procedure well and had no immediate complications.

 
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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 Key7057988
MDR Text Key92902199
Report Number1016427-2017-00810
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
Report Date 12/26/2017
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? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2017
Device Catalogue Number466F220A
Device LOT Number16066554
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 Received11/30/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/31/2014
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: 11/24/2017 Patient Sequence Number: 1
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