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

Model Number	7700FB32
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Endocarditis (1834); Dizziness (2194); Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 4 years and 5 months post implant of this 32mm mitral annuloplasty 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
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
Medtronic received additional information that changed the event description and device relatedness of this previously reported event.There is no evidence to suggest the device caused or contributed to a serious injury.Updated data: a.4: weight in lbs: b.5: event description b.7: relevant history h.6: coding 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 reported the reason for replacement as severe mitral regurgitation and ring dehiscence due to subacute endocarditis.It was further reported that the annuloplasty band was explanted and replaced with a 29mm valve of a different manufacturer.It was also noted that the patient had symptoms of dizziness and dyspnea.No additional adverse patient effects were reported.

• Brand Name: SIMUPLUS
• 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: 23474028
• Report Number: 9617601-2025-02504
• Device Sequence Number: 18781245
• Product Code: KRH
• UDI-Device Identifier: 00763000271015
• UDI-Public: (01)00763000271015(17)250717
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• 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): 12/09/2025

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: 07/17/2025
• Device Model Number: 7700FB32
• Device Catalogue Number: 7700FB32
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/09/2025
• Date Device Manufactured: 07/23/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 76 KG