MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 23; HEART-VALVE, MECHANICAL

Model Number ONXACE-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Transient Ischemic Attack (2109)

Event Date 08/24/2022

Event Type  Injury  

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 Description

According to the initial report received via email on (b)(6) 2022 from clinical research, "patient is subject #243 in the on-x post approval study.The patient had an episode of sudden blindness in right eye lasting 1 minute on (b)(6) 2022.The patient did not seek medical attention at the time.After the research follow-up on (b)(6) 2022, the patient attended a&e where retinal tia was suspected, and the patient was referred to tia clinic.Ct normal.Fully resolved.No treatment required.Adjudication of this event determined it to be possibly valve-related.This investigation will be relegated to onxace-23, sn (b)(4).

Manufacturer Narrative

The manufacturing records for serial number (b)(6), 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.On (b)(6) 2018 (b)(6), sn (b)(6) was implanted in the aortic position in a 40-year-old male patient who was subsequently enrolled in the on-x low dose post approval study (pas) as subject # (b)(6).On (b)(6) 2022 one event was reported to the manufacturer of sudden blindness in the right eye for one minute.Manufacturing records for this valve show a product meeting all requirements and acceptable for distribution.On (b)(6) 2022 the patient reported to the research staff during a follow up visit that he had an episode of sudden blindness to his right eye that lasted one minute that occurred 2 days earlier on (b)(6) 2022 (1,635 days post implant).He did not seek treatment at the time of the incident.The staff referred the patient to the accident and emergency department, and he was diagnosed with ¿retinal tia [transient ischemic attack] suspected¿ and referred to a tia clinic for further follow up.A ct scan was completed with normal results and the event was fully resolved without any treatment required.Of note the subjects inr was recorded as 2.7 on (b)(6) 2022, 3 days after the event.The instructions for use [ifu] for the on-x valve lists thromboembolism as a potential adverse event for mechanical prosthetic valve recipients.If thromboembolism is the underlying cause of the tia, it occurs at a historical rate of 3.0% per patient-year for rigid heart valves [iso (b)(4)].Suspected retinal tia that resolved without treatment with unknown underlying cause.The event was adjudicated as ¿tia¿ and ¿valve related¿ by the on-x low dose post approval study (pas) complications adjudication committee (cac).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 AORTIC CONFORM EXT 23
• Type of Device: 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: 15788846
• MDR Text Key: 303568598
• Report Number: 1649833-2022-00056
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001464
• UDI-Public: 851788001464
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

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 Operator: Lay User/Patient
• Device Expiration Date: 05/23/2024
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 12/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other