MAUDE Adverse Event Report: MEDTRONIC MEXICO AVALUS ULTRA BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	400U25
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Stroke/CVA (1770); Muscle Weakness/Atrophy (1967); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that 1 day post implant of this 25mm aortic bioprosthetic valve, it was reported that a computed tomography (ct) discovered mild small vessel ischemic disease, and a magnetic resonance imaging (mri) discovered an acute infarction of the left hemipons with no acute hemorrhage, indicative of a stroke.It was also reported that the patient had global weakness and clumsiness described as difficulty moving extremities and hands.The left hemibody continued to improve, however the right sided deficits persisted.A stroke code was initiated, and on exam the patient had right sided hemibody weakness proximally, with mild dysarthria and mild dysmetria/clumsiness.Stroke imagining was conducted, and showed no evidence of hemorrhage, mass effect or evidence suggestive of ischemic stroke with no perfusion deficit.A computed tomography angiography (cta) discovered no evidence of large vessel occlusion or flow limiting stenosis.No intervention was reported.The patient hospitalization was prolonged due to this event.Subsequently, 7 days later, the patient was discharged and recovered/resolved.The event was assessed as possibly related to the device and the procedure.No additional adverse patient effects were reported.

• Brand Name: AVALUS ULTRA BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21085566
• Report Number: 9612164-2025-00093
• Device Sequence Number: 8386816
• Product Code: DYE
• UDI-Device Identifier: 00763000647056
• UDI-Public: 00763000647056
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P170006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: 400U25
• Device Catalogue Number: 400U25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/06/2025
• Date Device Manufactured: 04/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 111 KG