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 02/02/2023

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 complaint 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 in the ascend study experienced an ischemic stroke.

Event Description

According to the initial report received, patient in the ascend study experienced an ischemic stroke.

Manufacturer Narrative

The manufacturing records for onxaap-25 sn (b)(6) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.An onxaap - 25 with serial number (b)(6) was implanted on (b)(6) 2022 in a 52-year-old female with a past medical history of a bicuspid aortic valve and an aortic root dilation of 45mm.The subject was enrolled in the ascend study.On (b)(6) 2023 (136 days post implant) the patient presented with complaints of dysarthria and motor aphasia, a nihss stroke scale was performed with a score of 0.Further testing was completed to include a ct of the head, ct angio of the brain and ekg.The ct angio showed left distal m2 occlusion, and the ekg showed sinus rhythm with left bundle branch block (known).Her inr level was 1.47 upon admission and she was given additional anticoagulation in the form of lmwh (low molecular weight heparin).The event was given an end date of (b)(6) 2023 (13 days) and it was classified as resolved without sequelae.The discharge diagnosis given was: left distal m2 occlusion with embolic mechanism and cardioembolic etiology due to under coagulation.Thromboembolism is recognized as a potential adverse event in the instructions for use [ifu] and occurs at a historical rate of 1.6 %/valve-year for mechanical aortic valves [iso 5840].According to the treating physician the root cause of the thromboembolism was under coagulation, supported by an inr of 1.47 at admission.No further action is required.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., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 17574239
• MDR Text Key: 321518275
• Report Number: 1649833-2023-00030
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001532
• UDI-Public: 851788001532
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/01/2024
• Device Model Number: ONXAAP-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2021
• 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): Hospitalization; Life Threatening
• Patient Age: 52 YR
• Patient Sex: Female