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

Model Number ONX UNK

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Heart Failure/Congestive Heart Failure (4446)

Event Type  Death  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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 artivion is accurate or has been confirmed by artivion.

Event Description

A swedish study of patients aged 50 to 69 years old who underwent primary surgical aortic valve replacement (avr) between 2003 and 2018 using a mechanical valve experienced the following events: all-cause mortality, major bleeding, aortic valve reintervention, heart failure hospitalization, and stroke.Approximately 220 of the mechanical valves were on-x.

Manufacturer Narrative

The manufacturing records could not be reviewed as patient information, serial numbers, nor date of implants were provided.An article describing results from a nationwide observational cohort study if all patients aged 50 to 59 who underwent primary surgical avr in sweden 2003 to 2018 using a [brand] bioprosthesis or mechanical valve identified from the swedeheart register is reviewed here.It was published in jacc: advances in jan 2023 [jacc adv.2023 jun, 2 (4)].Data consists of 6,907 patients from sweden who underwent primary surgical avr 2003 to 2018 using a [brand] bioprosthesis (3,831) or a mechanical valve (3,076), approximately 220 of the valves were on-x mechanical valves.It is an observational cohort study to determine the long-term all-cause mortality, bleeding, heart failure hospitalization, aortic valve reintervention, and stroke rates after avr in patients aged 50 to 69 years according to whether a [brand] bioprosthesis valve or a mechanical valve was used.The overall cohort consisted of 74% male, average age 61.9 ± 5.2 years; the [brand] cohort consisted of 73% male, average age 64 ± 4.3 years and the mechanical cohort consisted of 75% male, average age 59.3 ± 5.0 years.The estimated cumulative incidence at 15 years for all-cause mortality, bleeding, heart failure, hospitalization, aortic valve reintervention and stroke rates are as follows.All- cause mortality was 37% in the mechanical valve group and 45% in the [brand] group, the between-group difference in all- cause mortality was -7.9%.Bleeding was 16% in the mechanical valve group and 9.7% in the [brand] group, the between-group difference was 6.6%.Heart failure hospitalization was 15% in the mechanical group and 14% in the [brand] group, the between-group difference was 0.1%.Aortic valve reintervention was 5.9% in the mechanical valve group and 13% the in [brand] group, the between-group difference was -7.3%.Stroke was similar in both groups at 14%.The authors conclude that survival was better after surgical avr in patients aged 50 to 69 years who received a mechanical valve than in those who received a [brand] bioprosthetic valve.There was no distinction given to type of mechanical valve used, we only know that approximately 220 of the 3076 mechanical valve patients were implanted with an on-x valve.The authors found that in patients aged 50 to 69 who underwent surgical avr, survival was better in those who received a mechanical valve than in those who received a [brand] bioprosthesis.Patients with a mechanical valve had less risk of aortic valve reintervention but a higher risk of bleeding complications.The survival advantage associated with a mechanical valve was substantial in patients aged 50- 59 years, suggesting that it may be prudent to adjust the current american college of cardiology/american heart association valvular heart disease guideline to recommend a mechanical valve for patients up to 60 years.This event does not identify additional hazards or modify the probability and severity of existing hazards, and the ifu adequately communicates risk.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 artivion is accurate or has been confirmed by artivion.

Event Description

A swedish study of patients aged 50 to 69 years old who underwent primary surgical aortic valve replacement (avr) between 2003 and 2018 using a mechanical valve experienced the following events: all-cause mortality, major bleeding, aortic valve reintervention, heart failure hospitalization, and stroke.Approximately 220 of the mechanical valves were on-x.

• Brand Name: ON-X VALVE UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 17837918
• MDR Text Key: 324520503
• Report Number: 1649833-2023-00036
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONX UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention; Life Threatening; Hospitalization