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

Model Number	ONXAAP-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhagic Stroke (4417)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received, study patient experienced a hemorrhagic stroke on (b)(6) 2022, 7-days following implant with the device (implanted on (b)(6) 2022).
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.
Additional Manufacturer Narrative
The manufacturing records for onxaap-21, 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 [non-artivion] 19mm valve in 2014.The subject was enrolled in the study and this event refers to study patient.On (b)(6) 2022 (7 days post implant) during a one-hour neurological check it was found that the patient had a change in her pupils and she was sent for a ct angiogram with and without contrast of her head at 0155 on (b)(6) 2022.The impression of the cta was ¿evolving left mca territory infarction with overall increasing cytotoxic edema resulting in worsening mass effect on the left lateral ventricle with increasing left to right midline shift, which now measures approximately 0.9 cm, and early uncal herniation.There small area of petechial hemorrhage in the left parietal lobe¿ and ¿re-demonstrated occlusion at the mid posterior m2 left mca.¿ on (b)(6) 2022 (10 days post implant) a follow up ct head without contrast was performed as anticoagulation was started.It showed no interval change from (b)(6).On (b)(6) 2022 (11 days post implant) another ct head without contrast was performed to evaluate the evolution of the stroke, it showed ¿evolving left mca territory infarction with small amount of hemorrhage and approximately 8 mm midline shift.No new hemorrhage.On (b)(6) 2022 (14 days post implant) a follow up ct head without contrast was performed for new findings of ams [altered mental status], it showed ¿evolving left mca infarction with a small amount of hemorrhagic transformation.The mass effect and midline shift and slightly improved.No new acute findings.The ct performed on (b)(6) was the last included with the provided medical records.The patient was also referred for speech, physical and occupational therapy and at the time of discharge had more movement in the right upper and lower extremities and was on a regular diet with thin liquids.The ifu does list hemorrhage and stroke as potential complications and bleeding events occur at a historical rate of 1.6 %/valve-year.However, it is unknown if this stroke is related directly to the valve performance or if it is a case of hemorrhagic conversion of the earlier ischemic stroke.The latter explanation is more likely due to the timing of the hemorrhagic event 7 days after the ischemic event and the results of the (b)(6) 2022 cth that shows ¿evolving left mca infarction with a small amount of hemorrhagic transformation.¿ 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.References: on-x® ascending aortic prosthesis with the vascutek gelweave valsalvatm graft, instructions for use.Iso 5840-2:2021 (e) cardiovascular implants - cardiac valve prostheses, annex i.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESISWITH 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: 15933756
• Report Number: 1649833-2022-00061
• Device Sequence Number: 20473796
• 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
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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 Model Number: ONXAAP-21
• Device Catalogue Number: ONXAAP-21
• Is the Reporter a Health Professional?: No
• 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: 12/07/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2018
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 99 KG