MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMUFORM; RING, ANNULOPLASTY

Model Number	7800RR32
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Literature was reviewed regarding a 79-year-old female patient who ten months prior underwent mitral valve repair with implant of a medtronic simuform annuloplasty ring and placement of neochordae from the antero-lateral papillary muscle (apm) to the posterior leaflet. more recently the patient presented with congestive heart failure and severe intra-annular mitral regurgitation (mr) secondary to restrictive anterior leaflet motion.  the authors hypothesized that the neochordae placed on the posterior leaflet was causing the restriction by wrapping around a native chordae attached to the anterior leaflet.  subsequently the patient underwent surgery where the anterior leaflet was released by cutting the chordae between the apm and the anterior leaflet, and then a transcatheter edge-to-edge repair was successfully performed.The patient was discharged 5 days later.  no further information was provided pertaining to medtronic products.
Additional Manufacturer Narrative
Citation: bonnet et al.Transcatheter antegrade electrosurgical laceration of mitral valve chordae followed by transcatheter edge-t o-edge repair/ jacc cardiovasc interv.2024 feb 26;17(4):577-579.Doi: 10.1016/j.Jcin.2023.12.007.Epub 2024 jan 17.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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
A review of the medtronic global complaint handling database with the provided unique device identifier numbers found no previous records.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 from the physician/author provided the device unique device identifier (serial number (b)(6) and the patient's weight of 54 kg.No further details were provided.

• Brand Name: SIMUFORM
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19188636
• Report Number: 2025587-2024-02583
• Device Sequence Number: 7640313
• Product Code: KRH
• UDI-Device Identifier: 00763000271503
• UDI-Public: 00763000271503
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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 Expiration Date: 08/27/2026
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/24/2024
• Date Device Manufactured: 09/07/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 54 KG