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

Model Number	900SFC228
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Atrial Flutter (1730); Heart Block (4444)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 3 days post implant of this 28mm tricuspid annuloplasty band, it was reported that the patient developed complete heart block with junctional rhythm confirmed by electrocardiogram (ecg).It was stated that a repeat ecg the following day demonstrated the same result along with atrial fibrillation also being observed.It was noted that the transient atrial fib rillation resolved spontaneously.It was mentioned that the standard of care arrhythmic medication was held due to complete heart block.It was later reported that the 8 days post implant of the band, the patient developed paroxysmal atrial flutter.It was stated that another ecg performed 9 days post implant of the band showed the presence of atrial flutter.It was reported that 10 days postimplant of the band, a leadless dual-chamber pacemaker was successfully implanted with intrinsic rhythm being atrial flutter.It was mentioned that arrhythmic medication was then initiated after pacemaker implant.It was also reported that 13 days post implant of the band, due to persistent atrial flutter, the patient underwent a successful cardioversion to sinus rhythm.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.

• Brand Name: TRI-AD BAND
• 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: 21547890
• Report Number: 9612164-2025-01223
• Device Sequence Number: 15466448
• Product Code: KRH
• UDI-Device Identifier: 00763000102319
• UDI-Public: 00763000102319
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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 Model Number: 900SFC228
• Device Catalogue Number: 900SFC228
• 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: 02/21/2025
• Initial Report FDA Received Date: 03/07/2025
• Date Device Manufactured: 08/15/2024
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American