MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
|
Back to Search Results |
|
Model Number EVOLUTFX-23 |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problems
Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Fever (1858); Unspecified Infection (1930); Syncope/Fainting (4411)
|
Event Date 07/21/2023 |
Event Type
Death
|
Manufacturer Narrative
|
Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted. select patient information cannot be included in the regulatory report due to regional privacy regulations. 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 1 month following the implant of this transcatheter bioprosthetic valve, the patient developed a fever and syncope due to paroxysmal atrio-ventricular (av) block.7 days later, the patient was transferred to another hospital where the patient had an external pacemaker placed.Subsequently, bacteremia was observed, and antibiotic treatment was provided.Approximately 1 month later, a leadless permanent pacemaker was implanted.3 months and 25 days following the implant of the valve, the patient was found in a coma and rushed to the hospital.A cerebral infarction was observed.5 months and 15 days following the implant of the valve, the patient subsequently died.The cause of death was cerebral infarction.Per the physician, the valve and the valve implant procedure did not cause or contribute to the death.
|
|
Search Alerts/Recalls
|
|
|