MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC STANDARD EXT 19; HEART-VALVE, MECHANICAL

Model Number	ONXAE-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/25/2020
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 cryolife is accurate or has been confirmed by cryolife.
Event or Problem Description
According to the initial report received, "[.] from children¿s hospital in omaha called to inform us of a patient death.This [patient] died on (b)(6) 2020 from congestive heart failure and renal failure.".
Additional Manufacturer Narrative
Clinical / medical performed a review of the available information.Onxae-19 sn: (b)(6) was implanted on (b)(6) 2020 in the tricuspid position of a [patient] as part of multiple surgeries this patient experienced due to congenital cardiac malformation: mitral atresia, ventricular septal defect, transposition of the great arteries.The patient also had repeated tricuspid valve replacements due to thromboses, right atrial thrombus, and pre-existing complete heart block thought to be a consequence of infection.Implantation of the on-x valve was deemed successful per the operative notes with good prosthetic valve function and stable separation from extracorporeal membrane oxygenation.However, the patient died on (b)(6) 2020 (19 days postop) from congestive heart failure (chf) and renal failure.While the on-x surgery was considered successful, the patient did not survive long term.There is no information beyond the terms chf and renal failure to help us understand why they occurred.There are multiple reasons for either to occur, but since we have no further information, we also have no evidence to suggest the on-x valve made any contribution to these complications or death of the patient either.The on-x instructions for use acknowledge death as a potential consequence of a prosthetic valve replacement complication [ifu], but in this case, while we know the death is attributed to chf and renal failure, we do not know what, if any, contribution the on-x valve made to either of those conditions.The patient's death is attributed to congestive heart failure and kidney failure.There is no evidence that the valve contributed to either of these complications or failed to perform as intended.Should additional information become available, it will be reviewed and a need for investigation will be determined then.Risk management reviewed the available information.The on-x heart valve risk management file thoroughly identifies the process and product hazards for indication.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.The root cause for this event is congestive heart failure and kidney failure; however, there is no evidence the valve contributed to either of these events.There is no indication that an error or deficiency occurred at cryolife and all risks identified have been mitigated as far as possible and 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 cryolife is accurate or has been confirmed by cryolife.

• Brand Name: ONX AORTIC STANDARD EXT 19
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 10560553
• Report Number: 1649833-2020-00039
• Device Sequence Number: 1218802
• Product Code: LWQ
• UDI-Device Identifier: 00851788001389
• UDI-Public: 00851788001389
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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
• Operator of Device: No Information
• Device Expiration Date: 04/20/2023
• Device Model Number: ONXAE-19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death