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

Model Number	7800RR32
Medical Device Problem Codes	Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 32mm mitral annuloplasty ring was implanted and explanted on the same day during a procedure.No patient complications have been reported as a result of this event.
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
Sections updated: b.2 b.5 g.6 h.2 h.6.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
Additional information received reported that the reason for replacement was paravalvular leak.No additional adverse patient effects were reported.
Event or Problem Description
Additional information was received that reported the leak as residual regurgitation, and the annuloplasty ring was explanted and replaced with another manufacturers bioprosthetic valve.It was further reported that the valve did not malfunction.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated data: b.5: event description d3: mfr name, postal code, unique identifier (udi) #: h6: 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: SIMUFORM
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22338565
• Report Number: 9612164-2025-03182
• Device Sequence Number: 9401040
• Product Code: KRH
• UDI-Device Identifier: 00763000271503
• UDI-Public: (01)00763000271503(17)300108(21)K056393
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K201449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2025

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: 7800RR32
• Device Catalogue Number: 7800RR32
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 07/10/2025; 07/14/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/14/2025; 07/25/2025
• Date Device Manufactured: 01/08/2025
• 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: 65 YR
• Patient Sex: Female