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 Hematoma (1884)

Event Date 03/03/2013

Event Type  Injury  

Event Description

According to the initial report, patient is subject #040 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 3mar2013 (55 days post implant) while he was in the hospital recovering from repair of a periaortic leak with a large pseudoaneurysm he noted his left pupil was dilated.A ct of the head was performed and showed small right frontal intraparenchymal hemorrhage and a stable but slightly enlarged left tentorial subdural hematoma.Patient was diagnosed with a right frontal lobe iph from septic embolus according to reporting from the site on the digital crf.Pt was discharged home on (b)(6) 2013 to follow up with cardiology, infectious disease and neurology.

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 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) 2013 (55 days post implant) while he was in the hospital recovering from repair of a periaortic leak with a large pseudoaneurysm he noted his left pupil was dilated.A ct of the head was performed and showed small right frontal intraparenchymal hemorrhage and a stable but slightly enlarged left tentorial subdural hematoma.Patient was diagnosed with a right frontal lobe iph from septic embolus according to reporting from the site on the digital crf.Pt was discharged home on (b)(6) 2013 to follow up with cardiology, infectious disease and neurology.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 ; GG 30144 ; 7704193355
• MDR Report Key: 18592434
• MDR Text Key: 333897049
• Report Number: 1649833-2024-00010
• 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

• Date FDA Received: 01/26/2024
• 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
• Date Manufacturer Received: 01/19/2024
• Date Device Manufactured: 05/01/2012
• 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: 24 YR
• Patient Sex: Male