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

Model Number ONXA UNK

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the publication "outcomes after mechanical aortic valve replacement in children and young adults with congenital heart disease" by myers et, the site reviewed the survival and associated thrombo-embolic or bleeding complications after mechanical avr.The valves implanted were a st jude valve in 79 (62%), on-x in 45 (35%) and carbomedics in 3 (2.4%) patients.Median valve size was 23 mm (21-25).Mid- to long-term follow-up of the initial adult patients who received the on-x valve have been reported with favorable mortality rates and low linearized rates of thromboembolism (0.6 and 1.8% per patient-year, respectively), bleeding (0.4% and 0.9% per patient-year) and reoperation (0.2% and 1.2% per patient-year).

Manufacturer Narrative

A review was made of the available information.In a publication analyzing the outcomes of a pediatric mechanical avr (aortic valve replacement) population at a single institution, the product in question performed at least as well as the other types of valve, with a probable advantage in the prevention of pannus formation.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to the publication "outcomes after mechanical aortic valve replacement in children and young adults with congenital heart disease" by myers et, the site reviewed the survival and associated thrombo-embolic or bleeding complications after mechanical avr.The valves implanted were a st jude valve in 79 (62%), on-x in 45 (35%) and carbomedics in 3 (2.4%) patients.Median valve size was 23 mm (21-25).Mid- to long-term follow-up of the initial adult patients who received the on-x valve have been reported with favorable mortality rates and low linearized rates of thromboembolism (0.6 and 1.8% per patient-year, respectively), bleeding (0.4% and 0.9% per patient-year) and reoperation (0.2% and 1.2% per patient-year).

• Brand Name: ON-X AORTIC VALVE UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 8045768
• MDR Text Key: 126419531
• Report Number: 1649833-2018-00162
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXA UNK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/11/2018
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other