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 Problems Valvular Insufficiency/ Regurgitation (4449); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: d-evolutfx-34; product type: delivery catheter system (dcs); product id: l-evolutfx-34; product type: compression loading system (cls).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 was implanted.During a post balloon aortic valvuloplasty (bav) with a non-medtronic 23 millimeter (mm) balloon, the patient was rapid paced.There was a loss of pacing capture, which caused the valve to dislodge above the annulus.There was no coronary obstruction and hemodynamics remained stable.A second valve was loaded.The first valve was attempted to be snared into a higher position in the ascending aorta, however was unsuccessful.It was discussed that implanting another evolut fx would be difficult due to the position of the first valve, and there was risk of coronary obstruction and frame interaction.A non-medtronic valve was implanted successfully.The second 34fx valve was not implanted.No additional adverse patient effects were reported.

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

Additional information was received indicating that a pre-implant balloon aortic valvuloplasty (bav) was performed using a 23 millimeter (mm) non-medtronic (cristal) balloon.The deployment starting point was at the bottom of the pigtail catheter.Prior to dislodgement, the valve was implanted at a depth of 3mm on the non-coronary cusp (ncc) and 4-5mm on the left coronary cusp (lcc).A post-implant bav was performed due to mild paravalvular leak (pvl), and the valve subsequently dislodged aortic.It was noted that a non-medtronic (safari) guidewire was used during the procedure.

• 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: 18976187
• MDR Text Key: 338551664
• Report Number: 2025587-2024-01891
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/01/2024
• Date Device Manufactured: 01/30/2024
• 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
• Patient Sex: Male