MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX ASCENDING AORTIC 27/29; HEART-VALVE, MECHANICAL

Model Number	ONXAAP-27/29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	04/05/2022
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 is accurate or has been confirmed by artivion.
Event or Problem Description
Patient (b)(6) in the ascend study experienced three (3) adverse events that were possibly related to the implanted on-x valve [onxaap-27/27 sn (b)(4)]: (b)(6) 2022: seizure; (b)(6) 2022: cardiac arrhythmia; (b)(6) 2022: mediastinal hematoma overlying the right ventricle with compression.This investigation will be relegated to the (b)(6) 2022 event.
Additional Manufacturer Narrative
The manufacturing records for onxaap-27/29, serial number (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 27/29 with serial number (b)(6) was implanted on (b)(6) 2022 in a 32-year-old male with a past medical history of an prior mechanical valve repair in 2009, end stage renal disease [esrd] status post bilateral nephrectomy due to congenital polycystic kidney disease, hypertension, severe obesity, and a thoracic aortic aneurysm with an aortic root of 5.4cm severe, aortic insufficiency with an ejection fraction of 30% and mild mitral regurgitation.The subject was enrolled in the ascend study.On (b)(6) 2022 (day of implant) the patient experienced seizure like activity approximately 2 hours after arrival to the csicu unit from the operating room.The activity lasted approximately 2 minutes and occurred only once, according to the adverse event form the event resolved without sequalae.The patient was treated with 2mg versed bolus, 500mg keppra bolus and his propofol drip was increased.His sbp upper limit was increased to 150mmhg, a neurologist consult was placed and a ct of the head and eeg were ordered.According the subsequent follow up note written the evening of (b)(6)2022 the patient was able to follow commands and move all 4 extremities and his pupils were equal and reactive bilaterally.The results of the neurology consult, head ct and eeg were not provided for review with the other medical records.The instructions for use [ifu] do not specifically list a seizure as a known complication, however the seizure activity could be related to the surgical procedure itself or to the patient¿s medical history of esrd.The event of seizure is not a known complication listed in the ifu, however the seizure activity could be related to the surgical procedure itself or to the patient¿s medical history of esrd and is not directly related to the function of the valve.The on-x heart valve risk management file thoroughly identifies the process and product hazards for indication.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.Based on the available information, the root cause is unknown.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 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.

• Brand Name: ONX ASCENDING AORTIC 27/29
• 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: 15960113
• Report Number: 1649833-2022-00064
• Device Sequence Number: 11999692
• Product Code: LWQ
• UDI-Device Identifier: 00851788001549
• UDI-Public: 851788001549
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2023

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: 01/01/2024
• Device Model Number: ONXAAP-27/29
• Device Catalogue Number: ONXAAP-27/29
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 11/15/2022; 11/15/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/30/2023; 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• 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 Age: 32 YR
• Patient Sex: Male