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

Model Number	900SFC230
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	11/15/2025
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.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 2 days post implant of this of this 30mm tricuspid annuloplasty band, an electrocardiogram showed that the patient developed complete heart block (chb).Subsequently it was reported that on (b)(6) 2025 the patient successfully had a dual chamber leadless permanent pacemaker implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Pma code updated.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 data: b5 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
Additional information received reported that the patient had pre-existing arrhythmia (atrial fibrillation) prior to the heart valve implant.It was reported the physician does believe the heart valve or implant procedure possibly caused or contributed to the conduction disturbance.No additional adverse patient effects were reported.

• Brand Name: TRI-AD RING
• 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: 24512181
• Report Number: 9617601-2026-01574
• Device Sequence Number: 9870353
• Product Code: KRH
• UDI-Device Identifier: 00763000102326
• UDI-Public: (01)00763000102326(17)300801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2026

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 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: 02/20/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/04/2026; 03/19/2026
• Date Device Manufactured: 08/13/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White