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

Model Number EVOLUTFX-29

Device Problems Perivalvular Leak (1457); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Dysphasia (2195); Valvular Insufficiency/ Regurgitation (4449)

Event Date 09/15/2023

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 1 day following the implant of this transcatheter bioprosthetic valve, aphasia developed and the patient was diagnosed with cerebral infarction. chronic period rehabilitation was necessary at the hospital to which the patient was transferred, however, the patient's symptoms eventually improved.Per the physician, there was a causal relationship between the cerebral infarction and the procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated fields: b5 b7 added codes: e0621 a050405.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 day following the implant of this transcatheter bioprosthetic valve, aphasia developed and the patient was diagnosed with cerebral infarction. chronic period rehabilitation was necessary at the hospital to which the patient was transferred, however, the patient's symptoms eventually improved.Mild paravalvular leak (pvl) was also reported.Per the physician, there was a causal relationship between the cerebral infarction and the procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated b.5 updated d.4 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

Additional information was received that the stroke was ischemic.Per the physician, the stroke was not related to the valve or delivery catheter system (dcs), however was caused by splashing of blood clots due to the procedure.Thrombolysis was performed.The patient is recovering.

• 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: 18967175
• MDR Text Key: 338433478
• Report Number: 2025587-2024-01867
• 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,Followup,Followup
• Report Date: 04/19/2024

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: 03/15/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 03/15/2024; Not provided
• Supplement Dates FDA Received: 03/25/2024; 04/19/2024
• Date Device Manufactured: 03/08/2023
• 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; Disability