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

Catalog Number 466FXXXX

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient and is not available for inspection. As reported through the legal department (b)(6), the plaintiff underwent implantation of an optease retrievable vena cava filter. The device, inter alia, caused thrombosis of the vena cava and filter. 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. The device remains implanted in the patient and is not available for inspection. Manufacturing records (dhr) could not be reviewed, as the product catalog and lot number are not available. The purpose of a vena cava filter is to catch thrombus (a clot of blood formed within a blood vessel) from the lower extremities as it travels along normal blood flow patterns up towards the heart. Thrombus in the filter or within the vessel does not represent a device malfunction. Thrombosis in the filter is a well-known potential complication and occurs in approximately 3. 6 to 11. 2% of all patients. As such, it is addressed in the product¿s instructions for use (ifu). Factors that may contribute to thrombus may include patient factors, pharmacological and lesion characteristics. Based on the limited information available for review, there is no indication of a design or manufacturing related cause for this event. Therefore, no corrective action will be taken at this time. 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 implantation of an optease retrievable vena cava filter. The device, inter alia, caused thrombosis of the vena cava and filter. 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.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: THROMBECTOMY 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 Key: 5708812
• MDR Text Key: 46885754
• Report Number: 9616099-2016-00341
• 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

• 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 Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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?

• Event Location: No Information
• Date Manufacturer Received: 05/25/2016
• 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: Initial

Patient Treatment Data

Date Received: 06/09/2016 Patient Sequence Number: 1