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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 Problem Occlusion Within Device (1423)
Patient Problems Occlusion (1984); Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
Please note that device reported is a trapease vena cava filter and for which the catalog and lot numbers are not currently available. If obtained, a follow up report will be submitted within 30 days upon receipt. As reported in the legal brief in deed vs. Cordis, after an unspecified period of time when an optease vena cava filter was placed, the patient had severe pain and swelling of the lower extremity, blood clots, clotting and occlusion of ivc filter, requiring emergency surgery to remove the filter. The product was not returned for analysis. A review of the manufacturing records could not be conducted without a lot number. 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. Vena cava thrombus in the filter does not represent a device malfunction. The reported vena cava thrombosis could not be confirmed without films for review. Factors that may have influenced the event include patient, pharmacological and lesion characteristics. 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
As reported in the legal brief in deed vs. Cordis, after an unspecified period of time when an optease vena cava filter was placed, the patient had severe pain and swelling of the lower extremity, blood clots, clotting and occlusion of ivc filter, requiring emergency surgery to remove the filter.
 
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Brand NameUNKNOWN OPTEASE VENA CAVA FILTER
Type of DeviceTHROMBECTOMY SYSTEMS (DTK)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua 32580
MX   32580
7863133880
MDR Report Key5692916
MDR Text Key46360031
Report Number9616099-2016-00295
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 05/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2016
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: 06/01/2016 Patient Sequence Number: 1
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