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 Problems Endocarditis (1834); Hemorrhage/Bleeding (1888); Thromboembolism (2654)

Event Type  Injury  

Event Description

According to the initial report received via email on 07-june-2021 the presentation by kim js, kang y, shon sh, choi jw, hwang hy, kim kh.Long-term clinical outcome of on-x mechanical prosthetic valve in aortic and mitral position: a single center experience with 20 years follow-up results, presentation #000266 at 34theacts, barcelona, spain 2020 oct 8-10.The purpose of the study was to evaluate the long-term outcome of the on-x valve implanted in the left side of the heart for up to 20 years of follow-up.This was a single-center retrospective study of 861 on-x only recipients operated between february 1999 to december 2015.There were 344 avr, 325 mvr, and 192 double valve replacement (dvr) cases.Males dominated the aortic cases (63.1%) while females dominated the mitral (67.1%).Dvr was almost evenly split.Mean clinical follow-up was 10.1 ± 5.2 years for a cumulative follow-up of 8405.8 patient-years.Combined total results include 0.6%/pt-year of bleeding, 0.8%/pt-year of thromboembolism, 0.2%/pt-year of endocarditis, and 0.5%/pt-year of non-structural valve deterioration.This study also includes the on-x mitral valve: onxm unk.

Event Description

According to the initial report received via email on 07-june-2021 the presentation by kim js, kang y, shon sh, choi jw, hwang hy, kim kh.Long-term clinical outcome of on-x mechanical prosthetic valve in aortic and mitral position: a single center experience with 20 years follow-up results, presentation #000266 at 34theacts, barcelona, spain 2020 oct 8-10.The purpose of the study was to evaluate the long-term outcome of the on-x valve implanted in the left side of the heart for up to 20 years of follow-up.This was a single-center retrospective study of 861 on-x only recipients operated between february 1999 to december 2015.There were 344 avr, 325 mvr, and 192 double valve replacement (dvr) cases.Males dominated the aortic cases (63.1%) while females dominated the mitral (67.1%).Dvr was almost evenly split.Mean clinical follow-up was 10.1 ± 5.2 years for a cumulative follow-up of 8405.8 patient-years.Combined total results include 0.6%/pt-year of bleeding, 0.8%/pt-year of thromboembolism, 0.2%/pt-year of endocarditis, and 0.5%/pt-year of non-structural valve deterioration.This study also includes the on-x mitral valve: onxm unk.

• 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: 12009523
• MDR Text Key: 256728104
• Report Number: 1649833-2021-00022
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXA UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening