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

Model Number	638BL32
Medical Device Problem Codes	Calcified (1077); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 12 years and 4 months post implant of this 32mm mitral annuloplasty band, it was explanted and replaced with a 27mm bioprosthetic valve.The reason for the replacement was not reported.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.
Event or Problem Description
Medtronic received additional information which stated that a aortic valve replacement (avr) was also performed during the same procedure for severe aortic stenosis (as) and aortic regurgitation (ar).A 21mm mosaic aortic valve was implanted during the procedure.It was indicated that the patient had severe left ventricle dysfunction and required extracorporeal membrane oxygenation (ecmo) and impella support post operatively.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 b2 updated b5 updated b7 updated 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.
Event or Problem Description
Medtronic received additional information which stated that the patient had presented with a low left ventricle ejection fraction (ef) of 20% and acute decompensated heart failure primarily based on acute onset aortic valve regurgitation.It was reported that the reason for replacement of the mitral band was severe mitral valve regurgitation.It was reported that the mitral annuloplasty band was intact but there was severe mitral annular calcification.It was stated that the patient is doing well.

• 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: 20492319
• Report Number: 9612164-2024-04792
• Device Sequence Number: 19857667
• Product Code: KRH
• UDI-Device Identifier: 00613994751782
• UDI-Public: 00613994751782
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K052860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• 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): 02/20/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2014
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 01/30/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 01/15/2025; 02/20/2025
• Date Device Manufactured: 04/21/2011
• 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; Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 63 KG