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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

This investigation is currently on going.Any additional information will be provided in the follow-up report.This report is being submitted as required by 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, "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) 2011 with a surgeon made aap device and on-x aortic valve sn#: (b)(6).On (b)(6) 2019 (2941 days post implant) presented to the ed with a complaint of sudden onset of confusion and expressive aphasia.He was admitted for observation and a ct was completed, showing no acute hemorrhage and a small hypoattenuating focus in the left basal ganglia which is new since previous ct but is age-indeterminate.Inr was 2.4 at time of admission.Patient had resolution of symptoms within a few hours and was back to baseline at time of discharge home on (b)(6) 2019.Admitting diagnosis: transient episode of global aphasia.".

Event Description

According to the initial report received, "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) 2011 with a surgeon made aap device and on-x aortic valve sn (b)(6).On (b)(6) 2019 (2941 days post implant) presented to the ed with a complaint of sudden onset of confusion and expressive aphasia.He was admitted for observation and a ct was completed, showing no acute hemorrhage and a small hypoattenuating focus in the left basal ganglia which is new since previous ct but is age-indeterminate.Inr was 2.4 at time of admission.Patient had resolution of symptoms within a few hours and was back to baseline at time of discharge home on (b)(6) 2019.Admitting diagnosis : transient episode of global aphasia." this investigation is relegated to onxaap-25, sn (b)(6) (manufacturing date 01nov2009).Receipt of the adjudication form deemed the event not valve related.Per (b)(4) a complaint is ¿written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization¿s control or related to a service that affects the performance of such medical devices.¿ based on the information provided to artivion, there is no allegation of deficiency or resultant adverse event cause by the artivion product; therefore, further investigation is not warranted.

Manufacturer Narrative

Receipt of the adjudication form deemed the event not valve related.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 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: 18591786
• MDR Text Key: 333894624
• Report Number: 1649833-2024-00008
• 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: 11/01/2009
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Prefer Not To Disclose