MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC ANATOMIC EXT 23; HEART-VALVE, MECHANICAL

Model Number	ONXANE-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Diminished Pulse Pressure (2606)
Date of Event	01/10/2024
Type of Reportable Event	Death
Additional 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 or Problem Description
According to the initial report, surgeon suspected death by pea, pulseless electrical activity.Following the implant of this device, no deficiencies were noted.Patient left the operating room with normal sinus rhythm.Approximately two and a half hours later, the patient crashed on ecmo (extracorporeal membrane oxygenation).Resuscitation and imaging were performed by the surgeon.
Additional Manufacturer Narrative
Multiple attempts to obtain additional information were made with no response.According to the implant registration card received, the date of surgery was documented as (b)(6) 2024.The manufacturing records for onxane-23 sn (b)(6) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.The valve was not returned for inspection and no medical records were provided for this event.With this limited information we have no evidence to indicate what, if any, contribution the valve had to this unfortunate clinical outcome.Although there is no evidence of valve involvement, the instructions for use for the on-x valve lists death as a possible complication of mechanical heart valve replacement [ifu].Predictions of operative mortality after aortic valve replacement surgery show an operative mortality rate of (b)(4) (bowdish).The implanting surgeon stated they suspect the cause of death to be pea, with no other information provided we must rely on the expertise and knowledge of the surgeon to determine a root cause.However, with limited information we have no evidence to indicate what, if any, contribution the valve had to this unfortunate clinical outcome.Risk has been reduced as low as possible and overall residual risk is acceptable.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.B2: date of patient death.B3: date of event.
Event or Problem Description
According to the initial report, surgeon suspected death by pea, pulseless electrical activity.Following the implant of this device, no deficiencies were noted.Patient left the operating room with normal sinus rhythm.Approximately two and a half hours later, the patient crashed on ecmo (extracorporeal membrane oxygenation).Resuscitation and imaging were performed by the surgeon.

• Brand Name: ONX AORTIC ANATOMIC EXT 23
• Common Device Name: 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: 18789654
• Report Number: 1649833-2024-00021
• Device Sequence Number: 18082140
• Product Code: LWQ
• UDI-Device Identifier: 00851788001662
• UDI-Public: 851788001662
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXANE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 58 YR
• Patient Sex: Male