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

Model Number	7700FB28
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Stroke/CVA (1770); Muscle Weakness/Atrophy (1967); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Medtronic received information that 1 day post implant of this 28mm mitral annuloplasty band, it was reported that the patient developed right sided weakness, aphasia and right facial drop.It was stated that the patient underwent computed tomography imaging which revealed a left superior frontal lobe stroke, left venous sinus thrombosis and chronic left vertebral occlusion.A transthoracic echocardiogram (tte) performed noted thickened and focally calcified native mitral valve leaflets and there was a calcified segment of the posterior leaflet which appears to flail.The patient received "intermittent pressor therapy to meet map requirement" related to cerebral vascular accident (cva) and antibiotic medications were given.It was reported that the patients left toe appeared necrotic and a left lower extremity angiography performed 8 days later noted left proximal superficial femoral artery (sfa) stenosis with diffuse disease and an occlusion in the mid sfa.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated h6: img code added.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: 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: 18627355
• Report Number: 2025587-2024-00556
• Device Sequence Number: 8042298
• Product Code: KRH
• UDI-Device Identifier: 00763000270995
• UDI-Public: 00763000270995
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2024

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: 07/28/2025
• Device Model Number: 7700FB28
• Device Catalogue Number: 7700FB28
• 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: 01/24/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 07/04/2024
• Date Device Manufactured: 08/10/2020
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 48 KG