MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AVALUS ULTRA BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	400U23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2025
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
Medtronic received information that during the implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with an unknown product.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.Corrected data: b5: 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.
Event or Problem Description
Additional information was received that reported the patient presented to the facility in salvage critical condition, as they had severe aortic valve endocarditis.A positive blood culture was confirmed for the same organism found in a urine culture weeks prior.It was also reported that a vegetation could be seen on the patients native right and non-coronary cusp.The patient also had symptoms of shortness of breath.The 23mm aortic bioprosthetic valve was explanted and replaced with a 23mm valve of the same model.It was further reported that the reason for the replacement was after initial implant of the 23mm valve, re-inspection of the left ventricular outflow tract (lvot) revealed additional abscess and tissue destruction, requiring further debridement and patch reconstruction.No additional adverse patient effects were reported.
Event or Problem Description
Additional information was received that reported the 23mm aortic bioprosthetic valve was explanted and replaced with a 23mm valve of the same model.The reason for the replacement was not reported.It was further reported that the patient had severe aortic valve endocarditis, as they had a positive blood culture for the same organism found in a urine culture weeks prior.It was also reported that a vegetation could be seen on the patients native right and non-coronary cusp.The patient also had symptoms of shortness of breath.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated data: b.5: event description b.7: relevant history 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 ULTRA BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• 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: 23973109
• Report Number: 9617601-2026-00063
• Device Sequence Number: 9296116
• Product Code: DYE
• UDI-Device Identifier: 00763000647049
• UDI-Public: (01)00763000647049(17)280617(20)01
• 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: 2025
• 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,Followup
• Report Date (Section B): 02/19/2026

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 Model Number: 400U23
• Device Catalogue Number: 400U23
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 02/05/2026; 02/17/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/16/2026; 02/19/2026
• Date Device Manufactured: 06/18/2025
• 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: 66 YR
• Patient Sex: Male