MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV TRI-AD BAND; RING, ANNULOPLASTY

Model Number	900SFC232
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Tricuspid Valve Insufficiency/ Regurgitation (4453); Insufficient Information (4580)
Date of Event	12/09/2024
Type of Reportable Event	Death
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
It was reported that post implant of this 32mm tricuspid annuloplasty product, the patient was hospitalized due to cardiac decompensation with dyspnea on exertion and orthopnea.An echocardiogram performed noted moderate to severe regurgitation.It was stated that medications were given.No additional adverse patient effects were reported.
Event or Problem Description
Additional information was received that reported subsequently, 1 month later, the patient died.The cause of death was not received.Therefore, relatedness of the death to the annuloplasty ring could not be excluded.It is unknown whether an autopsy was performed.
Additional Manufacturer Narrative
Updated data: b.2: outcome attributed to adverse event b.5: event description 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.
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
Additional information was received that reported the cause of death as non-sudden cardiac death.No additional adverse patient effects were reported.

• Brand Name: TRI-AD BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21421284
• Report Number: 9612164-2025-00928
• Device Sequence Number: 20743607
• Product Code: KRH
• UDI-Device Identifier: 00763000102333
• UDI-Public: (01)00763000102333(17)270727(21)F161555
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2025

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: 900SFC232
• Device Catalogue Number: 900SFC232
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 12/17/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 12/16/2025; 12/19/2025
• Date Device Manufactured: 08/11/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization; Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 83 KG