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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX THROMBECTOMY SYSTEMS (DTK)

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CORDIS CORPORATION 466FXXXX THROMBECTOMY SYSTEMS (DTK) Back to Search Results
Model Number 466FXXXX
Device Problems Occlusion Within Device (1423); Difficult to Remove (1528)
Patient Problem Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
Please note that this file was previously reported in our previous quality system onevoice under (b)(4) and mfr report #9616099-2016-00570 and was migrated to our new quality system. No new information was received that changed the previous report. As reported through the legal department, a patient had an optease inferior vena cava (ivc) filter implanted which subsequently malfunctioned and caused injury and damages to the plaintiff including, but not limited to, blood clots, clotting and occlusion of the ivc filter, filter embedded in the wall of the ivc, and unable to be retrieved. As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. No additional information is available. The device has not been returned for analysis. Additionally, a device history record review could not be conducted as a sterile lot number was not received. Without procedural films for review, the reported events could not be confirmed and the exact cause could not be determined. The optease vena cava 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. Thrombosis does not represent a device malfunction. Additionally, the implantation and attempted retrieval dates are 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. Please note that this is the initial/final report for this product.
 
Event Description
As reported through the legal department (b)(6), the plaintiff had an optease inferior vena cava (ivc) filter implanted. The filter subsequently malfunctioned and caused injury and damages to the plaintiff including, but not limited to, blood clots, clotting and occlusion of the ivc filter, filter embedded in the wall of the ivc, and unable to be retrieved. As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. No additional information is available.
 
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Brand Name466FXXXX
Type of DeviceTHROMBECTOMY SYSTEMS (DTK)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave.
miami lakes FL 33152
Manufacturer (Section G)
CORDIS DE MEXICO
circuito interior norte #1820
juarez chihuahua
MX
Manufacturer Contact
cecil navajas
14201 nw60th ave.
miami lakes, FL 33014
MDR Report Key6076665
MDR Text Key59073492
Report Number1016427-2016-00105
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 Other Health Care Professional
Type of Report Initial
Report Date 11/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466FXXXX
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?
Distributor Facility Aware Date10/05/2016
Event Location No Information
Date Manufacturer Received10/05/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/03/2016 Patient Sequence Number: 1
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