MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX ASCENDING AORTIC 25; HEART-VALVE, MECHANICAL

Model Number ONXAAP-25

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

Patient Problem Ischemia Stroke (4418)

Event Date 04/20/2019

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, patient is subject #058 in the post-market clinical follow-up study protocol of the on-x ascending aortic prosthesis (aap) retrospective study and was implanted on 6dec2013 with a prefabricated aap device sn #(b)(6).On (b)(6) 2019 (1,961 days post implant) presented to the ed with complaints of right lower extremity weakness with onset of symptoms around 0930 the day of assessment and lasted approximately 2 hours.He presented first to a local ed where a head ct was performed with negative results and it was recommended, he be transferred to an increased level of care for an mri and lp, the patient refused and left ama.He then later presented to the referred ed and was evaluated again, he stated his symptoms had resolved he was admitted for observation and further testing.The mri showed a small ischemic injury in the left periventricular white matter , echocardiogram was unremarkable.He was diagnosed with likely small vessel stroke and discharged home on (b)(6) 2019 with neurology follow up.

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 judgment to reasonably 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.

Event Description

According to the initial report, patient is subject #(b)(6) in the post-market clinical follow-up study protocol of the on-x ascending aortic prosthesis (aap) retrospective study and was implanted on (b)(6) 2013 with a prefabricated aap device sn #(b)(6).On (b)(6) 2019 (1,961 days post implant) presented to the ed with complaints of right lower extremity weakness with onset of symptoms around 0930 the day of assessment and lasted approximately 2 hours.He presented first to a local ed where a head ct was performed with negative results and it was recommended, he be transferred to an increased level of care for an mri and lp, the patient refused and left ama.He then later presented to the referred ed and was evaluated again, he stated his symptoms had resolved he was admitted for observation and further testing.The mri showed a small ischemic injury in the left periventricular white matter , echocardiogram was unremarkable.He was diagnosed with likely small vessel stroke and discharged home on (b)(6) 2019 with neurology follow up.Receipt of the adjudication form deemed the event not valve related.

• Brand Name: ONX ASCENDING AORTIC 25
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd.; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 18592498
• MDR Text Key: 333899314
• Report Number: 1649833-2024-00011
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001532
• UDI-Public: 00851788001532
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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
• Device Model Number: ONXAAP-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 01/20/2024
• Supplement Dates FDA Received: 02/02/2024
• Date Device Manufactured: 05/01/2013
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male