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

Catalog Number ONXAAP-27/29

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967)

Event Date 03/02/2024

Event Type  Injury  

Event Description

Status post repair utilizing a #28 gel weave graft, aortic valve replacement utilizing a 27/29 on-x mechanical valve and ligation of the patent ductus arteriosus in (b)(6) 2023, was on coumadin with inr goal 2.5-3.5 for 3 months following valve placement and then decreased to 1.5-2.5 per recommendations from previous studies, inr 2 on arrival.Had been at lower goal for 3 weeks and presented to emergency department with left sided weakness on (b)(6) 2024.Found to have middle cerebral artery, cerebral vascular accident, underwent mechanical thrombectomy (b)(6) 2024.Echo (b)(6) 2024 showed echogenic structure noted within the left atrium along with the intra-atrial septum, not mobile.Transesophageal echocardiography ordered.

• Brand Name: MECHANICAL AORTIC VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES INC.; austin TX 78752
• MDR Report Key: 18857265
• MDR Text Key: 337348054
• Report Number: MW5152450
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ONXAAP-27/29
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White