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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 Occlusion Within Device (1423); Difficult to Remove (1528)
Patient Problems Occlusion (1984); Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
The product was not returned for inspection. As reported through the legal department, the plaintiff underwent placement of an optease retrievable vena cava filter. The device, inter alia, caused a large thrombus of the vena cava and filter and is irretrievable. As a result of the malfunction, the plaintiff has suffered life-threatening injuries and damages and requires extensive medical care and treatment. The plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses. No additional information is available at this time. The product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record review could not be performed. 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 or thrombus in the filter does not represent a device malfunction. The reported retrieval difficulty could not be confirmed without procedural films for review. The instructions for use note that ¿retrieval of the filter should not be attempted if thrombus is present in the filter and/or caudal to the filter. ¿ 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. Please note that this is the initial/final report for this product.
 
Event Description
As reported through the legal department (b)(6), the plaintiff underwent placement of a optease retrievable vena cava filter. The device, inter alia, caused a large thrombus of the vena cava and filter and is irretrievable. As a result of the malfunction, the plaintiff has suffered life-threatening injuries and damages and requires extensive medical care and treatment. The plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses. No additional information is available.
 
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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 Key5706035
MDR Text Key46786100
Report Number9616099-2016-00336
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number466FXXXX
Device Lot NumberUNKNOWN
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 Received05/25/2016
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

Patient Treatment Data
Date Received: 06/08/2016 Patient Sequence Number: 1
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