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

Model Number EVOLUTFX-34

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id {{d-evolutfx-34}}; product lot/serial number {{unknown}}; product type: {{0195-heart valves}}; implant date {{n/a}}; explant date {{n/a}} product id {{l-evolutfx-34}}; product lot/serial number {{unknown}}; product type: {{0195-heart valves}}; implant date {{n/a}}; explant date {{n/a}}.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.  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 during the implant of this transcatheter bioprosthetic valve, the valve dislodged deep at implan tation.11 days following implant of the valve, the valve failed due to paravalvular leak (pvl) and the patient was experiencing heart failure.Angiography was performed to determine the depth of the valve and to see the pvl.The valve frame was 11.2-16 millimeter's (mm) deep to the native annulus.Subsequently, a non-medtronic transcatheter valve was implanted valve-in-valve.It was noted that the depth of initial implant caused/contributed to the event.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: 19146759
• MDR Text Key: 340674708
• Report Number: 2025587-2024-02377
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370718
• UDI-Public: 00763000370718
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVOLUTFX-34
• Device Catalogue Number: EVOLUTFX-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Date Device Manufactured: 10/28/2023
• 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: 83 YR
• Patient Sex: Male