MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 25; HEART-VALVE, MECHANICAL

Model Number ONXACE-25

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

Patient Problems Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Thromboembolism (2654)

Event Date 08/02/2021

Event Type  Injury  

Event Description

According to the initial report, "patient is in the (b)(6) study.He attended the hospital (emergency department likely) with headaches, diagnosed with transient ischaemic attack / mature lacunar infarcts r caudate.No additional information is currently available; neurology record requested from the site.".

• Brand Name: ONX AORTIC CONFORM EXT 25
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 12917285
• MDR Text Key: 286645448
• Report Number: 1649833-2021-00043
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001471
• UDI-Public: 851788001471
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 05/21/2021
• Device Model Number: ONXACE-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/04/2021
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Male