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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problem Difficult to Remove (1528)
Patient Problem Injury (2348)
Event Date 12/05/2016
Event Type  Malfunction  
Event Description

As reported by the legal department, plaintiff underwent placement of defendant's optease vena cava filter on or about (b)(6) 2011. The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, filter embedded in wall of the ivc and filter unable to be retrieved. As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

 
Manufacturer Narrative

As reported by the legal department, a patient underwent placement of an optease vena cava filter on or about (b)(6) 2011. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter embedded in wall of the ivc and filter unable to be retrieved. As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record review could not be performed. Without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined. The reported event notes implantation of the filter on or about (b)(6) 2011; however, 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 has been shown to lead to explantation problems after 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.

 
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Brand Name466FXXXX
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
p.o. box 025700
miami FL 33152
Manufacturer (Section G)
CORDIS CORPORATION
p.o. box 025700
miami FL 33152
Manufacturer Contact
cecil navajas
po box 025700
miami, FL 33152
MDR Report Key6216081
MDR Text Key63662230
Report Number1016427-2016-00141
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,OTHER
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 06/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466FXXXX
Device Catalogue Number466F220A
Device LOT Number16444314
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/05/2016
Event Location No Information
Date Manufacturer Received03/09/2018
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

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