MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING; RING, ANNULOPLASTY

Model Number	800SR38
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.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 1 year and 3 months post implant of this 38mm mitral annuloplasty ring, it was reported that moderate mitral insufficiency was observed on a transthoracic echocardiogram.It was later reported that 2 years post implant of this ring, the patient had a transthoracic echocardiogram (tte) which showed mild mitral regurgitation.No intervention or adverse patient effects were reported.
Event or Problem Description
Additional information was received that reported subsequently, 1 year later, an echocardiogram discovered moderate mitral regurgitation.Another echocardiogram was performed 7 months later, which discovered severe mitral regurgitation.No intervention or additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated data: b.1: adv evnt/prod prob: b.2: outcome attributed to adverse event b.5: event description.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: SIMULUS SEMI-RIGID ANNULOPASTY RING
• 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: 20700388
• Report Number: 2025587-2024-06598
• Device Sequence Number: 6556246
• Product Code: KRH
• UDI-Device Identifier: 00643169182240
• UDI-Public: (01)00643169182240(17)240912(21)D264013
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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 Expiration Date: 09/12/2024
• Device Model Number: 800SR38
• Device Catalogue Number: 800SR38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/16/2025
• 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
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 62 KG