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

Model Number	ONXAAP-27/29
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to aap study - ascend - post market clinical follow-up study in patients treated with the on-x ascending aortic prosthesis (aap) adverse event report, patient experienced major bleeding event (b)(6) 2023.Date of implant: (b)(6) 2023.Led to a serious deterioration in the health of the subject, users or other persons as defined by one of the following: medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or body function.Start date: (b)(6) 2023.End date: (b)(6) 2023.Symptoms resolved without sequelae.Causal relationship to procedure: causal.Causal relationship to the aortic valve disease of heterogeneous ethology: not related.Causal relationship to onxaap: possible.Number of reoperations performed: 1.
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 ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.
Additional Manufacturer Narrative
According to aap study - ascend - post market clinical follow-up study in patients treated with the on-x ascending aortic prosthesis (aap) adverse event report, patient experienced major bleeding event 15mar2023.The manufacturing records for the onxaap-27/29 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.A review of the available information was performed.An onxaap 27/29 with serial number: (b)(6) was implanted on (b)(6) 2023 in a 60-year-old male with a past medical history of aortic stenosis and insufficiency with a bicuspid aortic valve that was very calcified, dilated ascending aorta and a thoracic aortic aneurysm.The subject was enrolled in the ascend study.Soon after the operation was complete the patient was transferred to the ¿ivc¿ unit and required a transfusion of 1-unit prbc¿s, 2 units ffp and 1-unit platelets.Despite the transfusion, he continued to ¿persist with increased debit and hemodynamic instability¿ and the decision was made to return to the operating room.During the reoperation a ¿periaortic hematoma and signs of recent bleeding¿ was discovered.After the revision procedure the patient remained hemodynamically stable, was able to be extubated without incident and discharged home on (b)(6) 2023 (12 days post operation).As this event occurred the same day of implant this would not be a spontaneous bleeding event due to the valve or anticoagulation therapy, but more likely a sequela of the trauma of surgery and therefore not a reportable bleeding event under the definition of akins, et al.[akins 2008].It is reported here only for the purpose of consistency in documenting adverse events made known to the manufacturer and does not qualify as a bleeding event for comparison to the historical record of valve performance.Nevertheless, hemorrhage is a potential adverse event of mechanical valve replacement as recognized in the instructions for use [ifu] as is death as a possible outcome.From the historical record, major hemorrhage for aortic mechanical prostheses occurs at a rate of 1.6 %/valve-year [iso 5840-2021].This event was most likely a sequela of the trauma of surgery and not related to the valve itself.No further action is required.A complaint and recall query was performed for onxaap-27/29 sn: (b)(6) to identify previously reported complaints or recalls associated with this complaint.No complaints or recalls were identified for this serial number.Based on the available information, a definitive root cause for this event cannot be determined.Additionally, this event was most likely a sequela of the trauma of surgery and not related to the valve itself.The manufacturing records 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.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion ¿ formerly cryolife/jotec and the ifu adequately communicates risk.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Artivion will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.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 ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.

• Brand Name: ON-X AAP UNKNOWN CONFIGURATION
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson lane; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson lane; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 16818120
• Report Number: 1649833-2023-00011
• Device Sequence Number: 15249076
• Product Code: LWQ
• UDI-Device Identifier: 00851788001549
• UDI-Public: 851788001549
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 10/01/2024
• Device Model Number: ONXAAP-27/29
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/29/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male