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

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 09/11/2011

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 333904538
• Report Number: 1649833-2024-00012
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001457
• UDI-Public: 00851788001457
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ONXACE-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Hospitalization