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

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.

• Brand Name: 466FXXXX
• Type of Device: THROMBECTOMY 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 Key: 6076665
• MDR Text Key: 59073492
• Report Number: 1016427-2016-00105
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• 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 Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 10/05/2016
• Event Location: No Information
• Date Manufacturer Received: 10/05/2016
• 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