MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE FILTER; THROMBECTOMY SYSTEMS (DQO)

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Injury (2348)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal department in (b)(6) vs.Cordis, the plaintiff was implanted with a cordis trapease inferior vena cava (ivc) filter.Approximately nine years and two months later, the filter was found to have embedded in the wall of the ivc preventing the device from being safely removed.An aneurysm developed near the site of the filter.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages.

Manufacturer Narrative

As reported by the legal department a cordis trapease inferior vena cava (ivc) filter was implanted in a patient.Approximately nine years and two months later, the filter was found to have embedded in the wall of the ivc preventing the device from being safely removed.An aneurysm developed near the site of the filter.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages.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 retrieval difficulty could not be confirmed.However, the cordis trapease® permanent vena cava filter is designed as a permanent vena cava filter.Six straight struts that contain a proximal and distal hooks are designed for fixation of the trapease filter to the vessel wall.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The off label use of this filter likely contributed to the difficulty experienced by the customer.The peripheral aneurysm may be caused by injury, infection and aging or other factors.Atherosclerosis, narrowing and slowing the flow of blood, may also contribute to the development of peripheral aneurysms.With the information available, the timing and clinical cause for the reported aneurysm could not be conclusively determined.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.

• Brand Name: TRAPEASE FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DQO)
• 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: 5841456
• MDR Text Key: 50998705
• Report Number: 9616099-2016-00484
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability