MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT; HEART-VALVE, MECHANICAL

Model Number	ONXAAP-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
According to the initial report received, study patient experienced pericardial effusion and cardiac tamponade, which required reoperation on (b)(6) 2022, 7-days following implant with the device.
Additional Manufacturer Narrative
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.During the investigation no non-conformances or deviations were found to be related to the complaint.Device was implanted on (b)(6) 2022 to treat a type a thoracic aortic aneurysm without rupture in a subject of unknown age and sex.The subject was enrolled in study.On (b)(6) 2022 (7 days post implant), the subject underwent reoperation described as a ¿mediastinal revision performed due to significant periaortic hematoma with left plural and pericardial effusion.¿ on (b)(6) 2022, 2 units of prbc¿s were transfused and the subject was diagnosed with acute respiratory failure secondary to recurrence of bilateral pleural effusion in the context of possible post-surgical pleuropericarditis (elevation of apr, persistent low-grade fever, negative cultures).On (b)(6) 2022, a left evacuation thoracentesis was performed, removing 1000ml of serous fluid.The outcome was recorded as ¿symptoms resolved without sequelae¿.As the event of tamponade and pericardial effusion happened 7 days post-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.Pericardial effusion and tamponade caused by fluid accumulation is most likely a consequence of a leaking suture line and is not likely related to the performance of the on-x valve itself.As the anticoagulation status is unknown, we cannot rule out an elevated inr as an exacerbating the event.The risk management and usability engineering file was reviewed and thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as far as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu (instructions for use).No new risks were identified.References: akins cw, et al.Guidelines for reporting mortality and morbidity after cardiac valve interventions, j thorac cardiovasc surg 2008;135:732-738.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.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT
• 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: 15640760
• Report Number: 1649833-2022-00052
• Device Sequence Number: 12191521
• Product Code: LWQ
• UDI-Device Identifier: 00851788001532
• UDI-Public: 851788001532
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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 Model Number: ONXAAP-25
• Device Catalogue Number: ONXAAP-25
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2020
• 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: Other
• Patient Sex: Unknown