MAUDE Adverse Event Report: MEDTRONIC MEXICO SIMUFORM; RING, ANNULOPLASTY

Model Number	7800RR38
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Prolapse (2475); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	10/22/2024
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.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 1 year and 1 month post implant of this 38mm mitral annuloplasty band, it was explanted and replaced with an unknown product.The reason for the replacement was reported as the p2 scallop of the posterior leaflet was prolapsed, leading to recurrent severe mitral regurgitation.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Corrected data: b.3: date of event, b.5: event description.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 1 year and 1 month post implant of this 38mm mitral annuloplasty ring, it was reported that an e chocardiogram (echo) discovered the p2 scallop of the posterior leaflet was prolapsed, leading to recurrent severe mitral regurgitation.No intervention or additional adverse patient effects were reported.Subsequently, 6 months later, it was explanted and replaced with an unknown product.No additional adverse patient effects were reported.

• Brand Name: SIMUFORM
• 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: 20747147
• Report Number: 9612164-2024-05476
• Device Sequence Number: 18233237
• Product Code: KRH
• UDI-Device Identifier: 00763000271237
• UDI-Public: 00763000271237
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: 04/13/2026
• Device Model Number: 7800RR38
• Device Catalogue Number: 7800RR38
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/03/2025
• Date Device Manufactured: 04/20/2021
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 61 KG