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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK)

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CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) Back to Search Results
Catalog Number 466FXXXX
Device Problems Filter (816); Expulsion (2933)
Patient Problem Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative

The product remains implanted and is thus not available for analysis. As indicated in a legal brief, plaintiff underwent placement of optease vena cava filter on or about (b)(6) 2014. The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, blood clots, clotting and occlusion of ivc filter. 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 device was not returned for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made. 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. Thrombus in the filter does not represent a device malfunction. Thrombosis in the filter is a well-known potential complication. Factors that may have influenced the event include patient, pharmacological and lesion. 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.

 
Event Description

(b)(6) as indicated in a legal brief, plaintiff underwent placement of optease vena cava filter on or about (b)(6) 2014. The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, blood clots, clotting and occlusion of ivc filter. 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.

 
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Brand NameUNKNOWN OPTEASE VENA CAVA FILTER
Type of DeviceTHROMBECTOMY SYSTEMS (DTK)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave.
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua 32580
MX   32580
7863133880
MDR Report Key5738598
MDR Text Key47839119
Report Number9616099-2016-00368
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 HEALTH PROFESSIONAL
Type of Report Initial
Report Date 05/24/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2016
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 Received05/24/2016
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/21/2016 Patient Sequence Number: 1
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