MAUDE Adverse Event Report: MEDTRONIC MEXICO RING PROFILE 3D 28MM; RING, ANNULOPLASTY

Model Number	680R28
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	08/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during the implant of this 28mm mitral annuloplasty ring, it was explanted and replaced with an unknown valve.The reason for the replacement was reported as the mitral valve leaflets did not coapt properly and severe mitral regurgitation.It was stated that the 28mm mitral annuloplasty ring malfunctioned.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.
Additional Manufacturer Narrative
Additional information - product analysis: upon receipt of the suspect complaint device at medtronic's quality laboratory, visual analysis showed three black multifilament sutures were attached to the ring.Yellow discoloration was observed on the ring.Multiple tears were observed on the fabric exposing the silicone and stiffener.One of the tears exposed a cut to the silicone.Fraying on the fabric and sutures were also observed.Radiography showed no evidence of fractures; however, showed a slight bend.Updated d9 updated h3 updated h6 correction - d3 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: RING PROFILE 3D 28MM
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc CA 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc CA 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20397357
• Report Number: 2025587-2024-05555
• Device Sequence Number: 19727582
• Product Code: KRH
• UDI-Device Identifier: 00613994759245
• UDI-Public: 00613994759245
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K073324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 680R28
• Device Catalogue Number: 680R28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female