MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV CG FUTURE BAND; RING, ANNULOPLASTY

Model Number	638BL34
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)
Date of Event	12/04/2025
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 34mm cg future band, 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
B1, b2, b5, b7 and h6 updated.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 post mitral valve repair using this 34mm cg future band, excessive regurgitation was noted.It was reported that a decision was made to re-attempt repair and the mitral valve was evaluated.The surgeon decided to downsize the valve, the 34mm cg future band was explanted and replaced with a 32mm annuloplasty band of the same model.It was stated that the annuloplasty product malfunctioned and was fully sutured and tested prior to removal.It was reported that post repair using the 32mm annuloplasty band, the band was tested and appeared hydrostatic.It was reported that mitral regurgitation was present post repair.The surgeon was unhappy with the repair and a decision was made to explant the 32mm annuloplasty band.The 32mm annuloplasty band was explanted and replaced with a 31mm mosaic bioprosthetic valve.It was reported that prior to the implant of the 31mm mosaic bioprosthetic valve, it was noted that the anterolateral anterior native valve leaflet was moderately calcified at the hinge point which may have contributed to the mitral regurgitation following repair.No additional adverse patient effects were reported.

• Brand Name: CG FUTURE BAND
• Common Device Name: RING, ANNULOPLASTY
• 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: 23973172
• Report Number: 9617601-2026-00065
• Device Sequence Number: 9296134
• Product Code: KRH
• UDI-Device Identifier: 00643169793620
• UDI-Public: (01)00643169793620(17)300806
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/05/2026

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: 638BL34
• Device Catalogue Number: 638BL34
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/05/2026
• Date Device Manufactured: 08/07/2025
• 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: Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male