MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AVALUS AORTIC TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	40023
Medical Device Problem Codes	Calcified (1077); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Endocarditis (1834); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	12/31/2025
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
It was reported 2 years and 11 months post implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with a 23mm aortic bioprosthetic valve of the same model.The reason for the replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that changed the event description and device relatedness of this previously reported event.There was no evidence to suggest the device caused or contributed to a serious injury.Updated data: a.4: weight in lbs: b.5: event description b.7: relevant history h.6: coding 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 also had a 34mm mitral annuloplasty band.The reason for aortic valve replacement was reported as calcification, mild aortic insufficiency and severe aortic stenosis due to aortic valve endocarditis infection.The patient had been previously hospitalized one month prior, as they also had an active endocarditis infection of their mitral valve.The patient had been taking antibiotic medication for the infective endocarditis.It was further noted that the patient was then admitted to the emergency department (ed) due to swelling in both of their legs up to their waist, and exacerbation of their existing congestive heart failure (chf).A transthoracic echocardiogram (tte) discovered an ejection fraction of 25%, and a positron emission tomography¿computed tomography (pet-ct) also discovered aortic valve endocarditis.A coronary artery bypass graft (cabg) procedure and mitral valve repair with chordal reconstruction due to mild mitral regurgitation in the setting of infective endocarditis was also performed concomitantly during this aortic valve replacement.Vegetation was present on the mitral valve.The mitral annuloplasty band remains implanted.No additional adverse patient effects were reported.

• Brand Name: AVALUS AORTIC TISSUE VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24108895
• Report Number: 9617601-2026-00354
• Device Sequence Number: 12216478
• Product Code: LWR
• UDI-Device Identifier: 00643169983199
• UDI-Public: (01)00643169983199(17)250629
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P170006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 02/17/2026

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 Expiration Date: 06/29/2025
• Device Model Number: 40023
• Device Catalogue Number: 40023
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 02/17/2026
• Date Device Manufactured: 06/30/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG