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 Code	Pseudoaneurysm (2605)
Date of Event	04/01/2022
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 a pseudoaneurysm and underwent reoperation on (b)(6), 2022, 16-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 (16 days post implant) the subject complained of chest pain and a ct angiogram was performed.It showed ¿pseudoaneurysm in the cranial/right portion which corresponds to the suture of the common trunk button and significant uptake of the contrast which may correspond to inflammation/infection.¿ a second surgical revision was performed and fresh periaortic hematoma and bleeding on the posterior side the prosthesis with observation of dissection of the button of the left coronary ostium.The treatment of a suture and a pericardium patch were applied; cultures were taken with negative results.At the time of discharge an echocardiogram and chest xray were performed.The echo noted ¿mechanical bentall with prosthesis with no signs of dysfunction.Remains of the periaortic hematoma still present in the annulus and around the tube in the proximal ascending aorta.Minimal pericardial effusion in the anterior sac, insignificant, without sign of hemodynamic compromise.The chest xray noted ¿no infiltrates or consolidations of the pulmonary parenchyma and no signs of pleural effusion.¿ the event was ¿resolved without sequelae¿ and the subject was later discharged home.There is no evidence that the valve contributed to the need for the reoperation.Nevertheless, the instructions for use [ifu] note that reoperation is a risk associated with the implantation of an aap device.The ifu also lists false aneurysm as a potential adverse event, which, in this case, precipitated the reoperation.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 during the course of the review.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: 15640604
• Report Number: 1649833-2022-00051
• Device Sequence Number: 15061967
• 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