MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER; HEART VALVE, MECHANICAL

Model Number	ONXACE-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	09/11/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial notification, patient is subject in the post-market clinical follow-up study protocol of the on-x ascending aortic prosthesis (aap) retrospective study.The patient was implanted with a surgeon made aap device and on-x aortic valve sn# (b)(6) on (b)(6) 2011.On (b)(6) 2011 (217 days post implant) the patient was admitted to the hospital with a diagnosis of tia.Patients inr was 1.6 at the time of the event.Per medical records provided ¿patient was admitted with tia symptoms.I nr was subtherapeutic.Lovenox initiated and coumadin dose was increased.Ct brain negative.Tee done to assess prosthetic valve without evidence of any associated thrombus.Neurology was consulted and felt.Likely a tia (if recurrence of sx's while therapeutic would consider carotid u/s).Patient also found to have triglycerides of 470 and hdl of 26 and was started on crestor 10mg and 2g fish oil.The patient will go home with lovenox and increased coumadin.¿ patient was discharged home on (b)(6) 2011 with recommendation of follow up in 4 weeks.
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.
Additional Manufacturer Narrative
Per the adjudication received, this event is not valve related.Per medical device reporting for manufacturers- fda guidance for industry and food and drug administration staff, section 2.16 an mdr report is not required when "you have information that would enable a person who is qualified to make a medical judgement to reasonable conclude that your device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury, if it were to recur." therefore, further investigation is not warranted.Per adjudication received, this event is not valve related; therefore, further investigation is not necessary.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• Common Device Name: HEART VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; building b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; bldg b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 18594556
• Report Number: 1649833-2024-00012
• Device Sequence Number: 8033807
• Product Code: LWQ
• UDI-Device Identifier: 00851788001457
• UDI-Public: 00851788001457
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: ONXACE-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2010
• 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: Life Threatening; Other; Hospitalization
• Patient Sex: Unknown