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

Model Number EVOLUTFX-34

Device Problems Material Invagination (1336); Perivalvular Leak (1457); Activation Failure (3270); Patient Device Interaction Problem (4001)

Patient Problems Low Blood Pressure/ Hypotension (1914); Valvular Insufficiency/ Regurgitation (4449); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  Injury  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve into a patient with a steep root angle and possible fused r-n, no pre-balloon aortic valvuloplasty (bav) was performed.The valve was 80% deployed and a leak was noted.Pressures were dropping and the valve was recaptured.The valve was deployed again however the valve did not fully expand.The valve was fully deployed and upon release, it was noted that the valve did not fully expand and there was an infold.Pressures continued to drop.Cardiopulmonary resuscitation (cpr) was initiated and the patient was placed on a pump.The patient stabilized and a post balloon aortic valvuloplasty (bav) was performed with a 26 millimeter (mm) non-medtronic valve.The leak resolved.An impella devic e was placed and the patient was weaned off the pump.The patient remained stable.It was reported that the procedure was delayed afor approximately 2 hours.No additional adverse patient effects were reported.

Manufacturer Narrative

Continuation of d10: product id d-evolutfx-34 product lot/serial number unknown product type: delivery catheter system (dcs) implant date implant date na explant date na product id l-evolutfx-34 product lot/serial number unknown product type: compression loading system (cls) implant date na explant date na 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 during the valve implant, the leak noted was severe paravalvular leak (pvl).

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.

• 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: 18980727
• MDR Text Key: 338625776
• Report Number: 2025587-2024-01910
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: 03/26/2024
• Date Device Manufactured: 08/15/2023
• 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
• Treatment: SEE H11...
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male