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

Model Number	ONXAAP-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	06/29/2022
Type of Reportable Event	Death
Event or Problem Description
According to the initial report, patient died due to a massive stroke, rt mca, and care was withdrawn.This patient was implanted with onxaap-23 sn (b)(4) on (b)(6) 2022 and died on (b)(6) 2022.
Additional Manufacturer Narrative
The manufacturing records for 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.An onxaap 23 sn (b)(6) was implanted on (b)(6) 2022 in the aortic position in a 43-year-old male patient.The manufacturer received a phone call on (b)(6) 2022 from the implanting hospital to report the patient¿s death on (b)(6) 2022.Multiple attempts have been made for further information with no response and no further information is forthcoming.The valve was not returned to the manufacturer, but the manufacturing records for this serial number document an acceptable product that met all specifications.On (b)(6) 2022 (26-days post implant) it was reported that the patient ¿died secondary to a massive stroke in the right mca (middle cerebral artery) and care was withdrawn¿.With the available information, it is unknown what, if any, contribution the valve had to the occurrence of this stroke or even if the stroke was hemorrhagic or thromboembolic in nature.Thromboembolism is recognized as a potential adverse event in the instructions for use [ifu] and occurs at a historical rate of 1.6 %/valve-year for mechanical aortic valves [iso 5840].If hemorrhagic, bleeding events also occur at a historical rate of 1.6 %/valve-year.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].Due to the lack of information, it is unknown what type of stroke occurred nor the factors that may have led to its occurrence and to the subsequent patient death.It is also unknown what, if any, contribution the valve had to the event.Therefore, the root cause is unknown as well.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, patient died due to a massive stroke, rt mca, and care was withdrawn.This patient was implanted with onxaap-23 sn (b)(6) on (b)(6) 2022 and died on (b)(6) 2022.

• Brand Name: ONX ASCENDING AORTIC 23
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15136738
• Report Number: 1649833-2022-00042
• Device Sequence Number: 17445177
• Product Code: LWQ
• UDI-Device Identifier: 00851788001525
• UDI-Public: 851788001525
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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 Expiration Date: 01/01/2023
• Device Model Number: ONXAAP-23
• Device Catalogue Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/30/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 43 YR
• Patient Sex: Male