MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY BAND; RING, ANNULOPLASTY

Model Number	800SC34
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Dyspnea (1816); Pleural Effusion (2010); Thromboembolism (2654); Pericardial Effusion (3271)
Date of Event	06/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) related to capa pr (b)(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
Medtronic received information that 10 days post implant of this 34mm mitral annuloplasty band, the patient presented to the emergency department (ed) with shortness of breath and dizziness.An electrocardiogram (echo) indicated a small posterolateral pericardial effusion.It was also reported that the patient had atrial fibrillation (a.Fib).On the same day, imagining indicated a subsegmental pulmonary embolism (pe) in the left upper lobe, trace right pneumothorax and small pneumomediastinum, small bilateral pleural effusions, and small pericardial effusion.Subsequently one day later, a second echo was performed and indicated small pericardial effusion. the patient was administered anticoagulant and given antiarrhythmic medication by drip.The patient is recovered/resolved.

• Brand Name: SIMULUS SEMI-RIGID ANNULOPASTY BAND
• 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: 18988418
• Report Number: 2025587-2024-01943
• Device Sequence Number: 14176680
• Product Code: KRH
• UDI-Device Identifier: 00643169182158
• UDI-Public: 00643169182158
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083683
• 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): 03/27/2024

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: 03/31/2026
• Device Model Number: 800SC34
• Device Catalogue Number: 800SC34
• 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: 06/20/2022
• Initial Report FDA Received Date: 03/27/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White