MAUDE Adverse Event Report: MEDTRONIC MEXICO CG FUTURE BAND; RING, ANNULOPLASTY

Model Number	638RL28
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a mitral valvuloplasty, a deformation of a 28 mm cg future mitral valve ring was observed, leading to a poor forming effect.The deformed mitral valve ring was explanted and replaced with another product of the same model during the procedure, and the operation was successfully completed.No patient complications have been reported as a result of this event.
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 deice had discoloration, and evidence of possible blood contact was noted on the ring.A remnant white multifilament suture was attached to the ring.Small needle holes show placement of implantation sutures.A tear was noted on the fabric cutting into the silicone and exposing the stiffener.Radiography revealed no evidence of fractures to the stiffener.The device history record (dhr) review was performed on the device; there were no issues identified during manufacturing that could have impacted this event.There were no non-conformances (ncmrs), reworks, or deviations.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.A conclusive cause of the poor forming effect could not be determined from the information available.The ring was explanted and replaced with another product of the same model during the procedure.Trends for these event types are being assessed per the criteria and no further action is recommended at this time.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.Medtronic will continue to monitor field performance for similar events should they occur.Updated data: d4, d9, h6.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 MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21524796
• Report Number: 9612164-2025-01159
• Device Sequence Number: 20917715
• Product Code: KRH
• UDI-Device Identifier: 00643169793521
• UDI-Public: (01)00643169793521(17)270608(21)F125383
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061127
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: 638RL28
• Device Catalogue Number: 638RL28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 06/09/2022
• 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 Sex: Male