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

Model Number	400U25
Medical Device Problem Codes	Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during the implant of this 25mm aortic bioprosthetic valve, it was explanted and replaced with another manufacturers product.The reason for the replacement was reported as after implant, a central jet causing aortic insufficiency was identified with poor coaptation.It was further noted that additional sutures were added, however the central jet and aortic insufficiency continued, therefore the valve was replaced.No additional adverse patient effects were reported.
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.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the valve exhibited discoloration consistent with blood contact.All leaflets were in a semi-closed position with a gap between their free margins.All leaflets were observed intact.Thrombus was observed on the commissures.All commissures and posts appeared intact.Conclusion: the investigation is in progress.A supplemental report will be submitted after completion of the investigation.H3: device evaluated? updated h6: updated the codes 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the valve exhibited discoloration consistent with blood contact.The valve appeared to have a segment of the sewing cuff inverted.A remnant of a green multifilament suture remains attached to the sewing ring.Small needle holes observed along the sewing cuff show placement of implantation sutures; also found on the sewing cuff were tears.On top of post 2, there was a tear observed.These findings may be associated with contact from a sharp instrument during the explant procedure.All leaflets were in a semi-closed position with a gap between their free margins.All leaflets were observed intact.All commissures and posts appeared intact.Conclusion: the investigation is in progress.A supplemental report will be submitted after completion of the investigation.Corrected the analysis.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: 24180283
• Report Number: 9617601-2026-00573
• Device Sequence Number: 15996805
• Product Code: DYE
• UDI-Device Identifier: 00763000647056
• UDI-Public: (01)00763000647056(17)280721(20)01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 400U25
• Device Catalogue Number: 400U25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• 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: 02/24/2026; 04/22/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/19/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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: Required Intervention; Life Threatening
• Patient Sex: Male
• Patient Weight: 100 KG