MAUDE Adverse Event Report: Medtronic Heart Valves Division CG Future Band; RING, ANNULOPLASTY

Model Number	638BL32
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during the implant of this 32mm mitral annuloplasty band, it was explanted and replaced with a 29mm mitral bioprosthetic valve.The reason for the replacement was reported as during the patients mitral valve replacement patient's native posterior and anterior leaflet prolapse was addressed and the band was used to repair the patients mitral valve.It was reported after the repair an intraoperative transesophageal echocardiogram (tee) showed a residual leak of 1.5 - 2+, and the physician determined that repair was not adequate, therefore the annuloplasty band was explanted and a 29mm mitral bioprosthetic valve was implanted.It was further reported post implant the transesophageal echocardiogram (tee) showed no obvious paravalvular leak, and the mitral valve was functioning appropriately with no gradient across the mitral valve.It was further noted that the patient was discharged on (b)(6) 2026.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.

• Brand Name: CG Future Band
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): Medtronic Heart Valves Division; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): Medtronic Heart Valves Division; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50397246
• Report Number: 2025587-2026-00938
• Device Sequence Number: 18435988
• Product Code: KRH
• UDI-Device Identifier: 00643169793613
• UDI-Public: (01)00643169793613(17)280815
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• 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
• Report Date (Section B): 08/23/2026

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: 638BL32
• Device Catalogue Number: 638BL32
• 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: Not provided
• Initial Report FDA Received Date: 08/23/2026
• Date Device Manufactured: 08/17/2023
• 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; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 320 LB