MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVOLUTFX-29

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Fever (1858); Pneumonia (2011)

Event Date 02/26/2024

Event Type  Injury  

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.

Event Description

Medtronic received information that following the implant of this transcatheter bioprosthetic valve, the patient had st-segment elevation after the valve was placed. coronary angiography and echocardiogram were performed but no problems were detected. the only adverse effect which could be considered was left bundle branch block. the position of the bioprosthetic valve was 3mm on the non-coronary cusp (ncc)and 4mm on the left coronary cusp (lcc).A permanent pacemaker was not implanted.One day following the valve implant procedure, the patient developed a fever and a computed tomography (ct) scan revealed a shadow.Pneumonia was diagnosed.The patient recovered after antibiotics were administered.Two days following the valve implant, the patient experienced a recurrence of symptomatic paroxysmal atrial fibrillation (afib).The patient was discharged from the hospital and considered for re-ablation.No additional adverse patient effects were reported.

• Brand Name: EVOLUT FX VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• 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: 19051503
• MDR Text Key: 339492780
• Report Number: 2025587-2024-02132
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2024

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
• Device Operator: Health Professional
• Device Model Number: EVOLUTFX-29
• Device Catalogue Number: EVOLUTFX-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/05/2024
• Date Device Manufactured: 10/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 79 KG