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

Model Number	7700FB26
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Bradycardia (1751); Non specific EKG/ECG Changes (1817)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the implant of this 26mm mitral annuloplasty band, it was reported that the patients "int ra-operative course was complicated by junctional rhythm".Two days post procedure, the patient developed atrial fibrillation, on day 3 post procedure, the atrial fibrillation converted back to junctional rhythm, and on day 4 post procedure, junctional rhythm "re- converted to atrial fibrillation." on day 5 post procedure, the patient "developed bradycardia requiring pacing", and on day 6 post procedure, the patient was "in sinus bradycardia to sinus rhythm with a rate of 50's-60's".It was reported that 16 days post procedure, the patient had a diagnostic electrocardiogram (ecg) which indicated atrial flutter with rapid ventricular response (rvr).The patient was given medication and converted back to sinus rhythm.It was recommended to the patient to undergo a cardioversion.Patient underwent cardioversion 47 days later.It was stated that the physician believes the band or implant procedure caused or contributed to the conduction disturbance as the patient did not have any history of arrhythmias prior to the band implant procedure.Subsequently, 4 months and 11 days later, the patient experienced a recurrence of atrial flutter and underwent cardioversion.No additional adverse patient effects were reported.

• Brand Name: SIMUPLUS
• 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: 18896253
• Report Number: 2025587-2024-01616
• Device Sequence Number: 18021149
• Product Code: KRH
• UDI-Device Identifier: 00763000271282
• UDI-Public: 00763000271282
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K201449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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 Model Number: 7700FB26
• Device Catalogue Number: 7700FB26
• 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: 08/04/2022
• Initial Report FDA Received Date: 03/13/2024
• Date Device Manufactured: 11/29/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White