MAUDE Adverse Event Report: ARTIVION, INC. ¿ AUSTIN ONX ASCENDING AORTIC 21; HEART-VALVE, MECHANICAL

Model Number	ONXAAP-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On-x ascend study patient (b)(6) experienced cardiac arrest on (b)(6) 2022 which led to a serious deterioration in the health of the patient and prolonged their hospitalization.Re-operation was performed on (b)(6) 2022.Cabg (coronary artery bypass graft) completed with the reanastamosis of the right coronary artery bypass graft due to concern about compromise to the blood flow to the right coronary artery.The on-x valve remains implanted.Outcome of the re-operation is symptoms resolved without sequelae.
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 21 with serial number (b)(6) was implanted on (b)(6) 2022 with a concomitant coronary artery graft bypass (cabg) x1 svg-rca in a 42-year-old female with a past medical history of svt, hypothyroid, hypertension, presumed asthma, congenital bicuspid aortic valve and ascending aortic aneurysm with a previous ascending aortic aneurysm repair in 2005 and an aortic valve replacement with a carbomedics 19mm valve in 2014.The subject was enrolled in the study and this event refers to the study patient.On (b)(6) 2022 (2 days post implant) the patient went into asystole overnight and was coded per acls protocols.She was reintubated and started on ino [ionotropic support].A bedside echo was performed that was concerning for rv dysfunction and lv emptying so she was given fluids and prbc and placed back on epi, norepinephrine, dopamine.On (b)(6) 2022 the clinical notes state ¿multiple codes overnight and this morning.¿ at 0721 the patient coded again and at 0844 a coronary angiogram was performed with a rca thrombus noted.She was then taken to the or at 1025 for a re-do cabg with reanastamosis of the right coronary bypass graft and placed on ecmo.After the re-do cabg procedure no further events of cardiac arrest were noted in the medical record.The adverse event of cardiac arrest is not specified in the ifu; however, the event of thrombus is.In this case it appears that the thrombus is related to the cabg procedure rather than the valve itself as the patient experienced no further events of cardiac arrest after the re-do cabg with reanastamosis of the right coronary bypass graft.The adverse event of cardiac arrest is not specified in the ifu; however, the event of thrombus is.In this case it appears that the thrombus is related to the cabg procedure rather than the valve itself as the patient experienced no further events of cardiac arrest after the re-do cabg with reanastamosis of the right coronary bypass graft.The patient was part of the study and there is not sufficient data to determine a product failure mode; thus, severity and occurrence is not evaluated.After the re-do cabg procedure no further events of cardiac arrest were noted in the medical record.The adverse event of cardiac arrest is not specified in the ifu; however, the event of thrombus is.In this case it appears that the thrombus is related to the cabg procedure rather than the valve itself as the patient experienced no further events of cardiac arrest after the re-do cabg.The manufacturing records indicate that all records were controlled, available for review, and met all specifications.There is no indication that an error or deficiency occurred at artivion formerly cryolife/jotec 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 artivion is accurate or has been confirmed by artivion.
Event or Problem Description
The study patient experienced cardiac arrest on (b)(6) 2022 which led to a serious deterioration in the health of the patient and prolonged their hospitalization.Re-operation was performed on (b)(6) 2022.Cabg (coronary artery bypass graft) completed with the reanastomosis of the right coronary artery bypass graft due to concern about compromise to the blood flow to the right coronary artery.The on-x valve remains implanted.Outcome of the re-operation is symptoms resolved without sequelae.No additional information is forthcoming.

• Brand Name: ONX ASCENDING AORTIC 21
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ARTIVION, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg.; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15870265
• Report Number: 1649833-2022-00058
• Device Sequence Number: 17814984
• Product Code: LWQ
• UDI-Device Identifier: 00851788001518
• UDI-Public: 851788001518
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2023
• Device Model Number: ONXAAP-21
• Device Catalogue Number: ONXAAP-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 02/14/2023
• Date Device Manufactured: 10/01/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CABG
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 42 YR
• Patient Sex: Female