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

Catalog Number 466FXXXX

Device Problem Expulsion (2933)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

The product remains implanted and is thus not available for analysis.As indicated in a legal brief, plaintiff underwent placement of optease vena cava filter on or about (b)(6) 2014.The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, blood clots, clotting and occlusion of ivc filter.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.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.Thrombus in the filter does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication.Factors that may have influenced the event include patient, pharmacological and lesion.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

(b)(6) as indicated in a legal brief, plaintiff underwent placement of optease vena cava filter on or about (b)(6) 2014.The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, blood clots, clotting and occlusion of ivc filter.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DTK)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave.; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5738598
• MDR Text Key: 47839119
• Report Number: 9616099-2016-00368
• 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: other
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization