MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CG FUTURE BAND; RING, ANNULOPLASTY

Model Number	638BL34
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during the implant of this 34mm mitral annuloplasty band, it was explanted and replaced with an 34mm annuloplasty band of the same model.The reason for the replacement was reported as the suture buckle had broken, which affected the implant of the lower valve ring.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
Updated data: e.Initial reporter : facility name:, street 1:, city:, country:, postal code: 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
The analysis and investigation is in progress.A supplemental report will be submitted after completion.B5, d9 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 the annuloplasty product was not fully sutured and tested prior to removal.No adverse patient effects were reported.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the band exhibited discoloration consistent with prior blood contact.A tear was observed on one of the eyelets, accompanied by damage to the green manufacturing suture.An additional tear was noted on the adjacent fabric.Aside from the eyelet suture damage, no defects were identified in the remaining manufacturing sutures along the band.Minor fraying was also observed on the fabric surface.The reported allegation of a broken suture buckle could not be assessed or confirmed, as the holder was not returned with the device.Conclusion: the investigation is in progress.A supplemental report will be submitted after completion of the investigation.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
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.

• 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 ; 091708096
• MDR Report Key: 23947947
• Report Number: 2025587-2026-00003
• Device Sequence Number: 10683768
• Product Code: KRH
• UDI-Device Identifier: 00643169793620
• UDI-Public: (01)00643169793620(17)260527
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052860
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/14/2026

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 Expiration Date: 05/27/2026
• Device Model Number: 638BL34
• Device Catalogue Number: 638BL34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 01/03/2026; 01/28/2026; 02/17/2026; 04/13/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/06/2026; 01/29/2026; 03/16/2026; 04/14/2026
• Date Device Manufactured: 05/28/2021
• 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
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 66 KG