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

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

Patient Problems Death (1802); Endocarditis (1834); Hemorrhage/Bleeding (1888); Thromboembolism (2654)

Event Date 12/01/2015

Event Type  Death  

Manufacturer Narrative

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

Event Description

Powerpoint presentation that will be presented at eacts meeting in october based on study: ¿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¿ by j.S.Kim, seoul, y.Kang, seoul, s.H.Sohn, seoul, j.W.Choi, seoul, h.Y.Hwang, seoul, k.H.Kim, seoul reported rates of mortality, bleeding, thromboembolism and prosthetic valve endocarditis, reoperation, and nonstructural valve deterioration from 861 patients.

Manufacturer Narrative

Pre-presentation slide set for upcoming surgeons¿ annual meeting [kim 2020] describing a single center experience with the on-x valve in the aortic (avr) and mitral (mvr) positions sometimes both (dvr) with up to 20 years follow-up.Implants occurred between february 1999 and december 2015 in 861 patients (avr n=344, mvr n=325, dvr n=192) using only the on-x valve.This is a retrospective analysis with follow-up completion of 93.4%, a mean follow-up of 10.1 ±5.2 years, and a cumulative follow-up of 8405.8 patient-years.Average age for avr is 53.2±11.8 years, mvr 50.4±10.1 years, and dvr 51±10.3 years.Gender is avr 63.1% male, mvr 32.9% male, and dvr 51.6% male.Analysis of early outcomes indicates no difference in early mortality between groups.Bleeding events (all positions combined) showed a rate of 0.6% / patient-year.This compares to the objective performance criteria (opc) in rigid prosthetic valves of 3.5% / pt-yr for all hemorrhage and 1.5% / pt-yr.For major hemorrhage [iso 5840:2005].Likewise, thromboembolism was 0.8% / pt-yr compared to opc of 3.0% / pt-yr.Endocarditis was 0.2% / pt-yr compared to opc of 1.2% / pt-yr.There were no reports of thrombosis unless this was recorded as a non-structural valve deterioration (nsvd).The presentation does not clearly indicate this definition.Nsvd was 0.5% / pt-yr.In brief, the on-x valve performed well within the expected event rates based upon the historical evidence.All of these events are recognized as potential adverse events associated with prosthetic valve replacement [ifu].The on-x risk management file was reviewed and found to thoroughly identify the process and product hazards for indications.Each individual hazard is mitigated and reduced as far as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.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.

• Brand Name: ON-X PROSTHETIC 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: 10593247
• MDR Text Key: 208777009
• Report Number: 1649833-2020-00040
• 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: company representative,study
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other