MAUDE Adverse Event Report: MEDTRONIC MEXICO AVALUS AORTIC TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	40021
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446)
Date of Event	03/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced heart failure and hemodynamic instability, as well as congestive heart failure (chf) as sociated with the implanted valve 40021 model 400 aor.The patient suffered from acute on chronic diastolic heart failure, class ii¿3, and profound lethargy, with severe bioprosthetic aortic valve stenosis per doppler criteria.Planned treatments included a cardia c computed tomography angiography (cta), transesophageal echocardiogram (tee), and cardiac catheterization to rule out significant coronary disease before considering aortic valve replacement.No patient complications have been reported as a result of this event.
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
Additional information was received that reported the patient is scheduled for a full redo-sternotomy replacement of the aortic valve.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated data: b.1: adv evnt/prod prob b.2: outcome attributed to adverse event b.5: event description 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.

• Brand Name: AVALUS AORTIC TISSUE VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 21739116
• Report Number: 9612164-2025-01641
• Device Sequence Number: 3981203
• Product Code: LWR
• UDI-Device Identifier: 00643169983182
• UDI-Public: 00643169983182
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P170006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2019
• Device Model Number: 40021
• Device Catalogue Number: 40021
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/16/2025
• Date Device Manufactured: 01/03/2018
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 80 KG