MAUDE Adverse Event Report: MEDTRONIC MEXICO TRI-AD RING; RING, ANNULOPLASTY

Model Number	900SFC230
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Syncope/Fainting (4411); Tricuspid Valve Insufficiency/ Regurgitation (4453); Insufficient Information (4580)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that 5 years and 1 month post implant of this 23mm tricuspid annuloplasty band, it was explanted and replaced with a 31mm bioprosthetic valve.The reason for the replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Correction: b5 - size of tricuspid annuloplasty band corrected from 23mm to 30mm.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 5 years and 1 month post implant of this 30mm tricuspid annuloplasty band, it was explanted and replaced with a 31mm bioprosthetic valve.The reason for the replacement was not reported.No additional adverse patient effects were reported.Additional information was received that reported the reason for replacement as moderate to severe tricuspid regurgitation.It was also reported that the patient presented to the hospital with symptoms of chest pain, dyspnea and syncope.No additional adverse patient effects were reported.
Event or Problem Description
Additional information was received that reported the reason for replacement as moderate to severe tricuspid regurgitation.It was also reported that the patient presented to the hospital with symptoms of chest pain, dyspnea and syncope.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated data: a.4: patient weight b.1: adv evnt/prod prob: b.2: outcome attributed to adverse event 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.

• Brand Name: TRI-AD RING
• 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: 20834697
• Report Number: 9612164-2024-05743
• Device Sequence Number: 15669734
• Product Code: KRH
• UDI-Device Identifier: 00763000102326
• UDI-Public: 00763000102326
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 02/17/2025

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: 11/30/2023
• Device Model Number: 900SFC230
• Device Catalogue Number: 900SFC230
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 01/21/2025; 02/17/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/13/2025; 02/18/2025
• Date Device Manufactured: 12/06/2018
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 112 KG