MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number ONXAE25

Device Problem Patient Data Problem (3197)

Patient Problem Stroke/CVA (1770)

Event Date 07/09/2015

Event Type  Injury  

Event Description

The patient had a stroke after coumadin dose was lowered to achieve lower inr levels stated in letter sent to patient and physician in charge of managing inr levels.It appears the letter prompted the physician to lower the coumadin at approximately 60 days (when letter was received) instead of 90 days.

• Brand Name: ON-X AORTIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson lane; building b; austin TX 78752
• MDR Report Key: 5180034
• MDR Text Key: 29318201
• Report Number: 5180034
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: ONXAE25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2015
• Event Location: Home
• Date Report to Manufacturer: 09/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 20 YR
• Patient Weight: 90