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

Model Number EVOLUTFX-29

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)

Patient Problem Valvular Insufficiency/ Regurgitation (4449)

Event Date 04/05/2024

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the patient was scheduled for tran catheter aortic valve replacement (tavr) due to aortic stenosis.The patient had a mean gradient (mg) > 100mmhg and aortic valve area (ava) of 0.4cm.The native valve was highly calcified. valve was inspected prior to use and an infold was noted to the second node, which was acceptable for patient use.Pre-implant bav was performed using a 20mm balloon, due to gradients and valve area.The balloon and sheath were removed, and the delivery catheter system (dcs) was inserted with ease.  while following proper cusp overlap protocol, valve appeared to be 2mm below the annulus on the non-coronary cusp (ncc)/right coronary cusp (rcc)/left coronary cusp (lcc). upon release, the valve dislodged above the annulus which appeared to be 2mm above the native annulus.Echocardiogram showed the patient's valve area was 1.6cm and mg of 13mmhg with moderate paravalvular leak (pvl).The decision was made to put in a second valve.Following protocol, the second valve was placed 4mm below the native annulus.Final results were mg: 5, no leak, ava: 3.5cm.Patient was alive with no injury or adverse symptoms.No procedural delay occurred.No additional adverse patient effects were reported.

Manufacturer Narrative

Continuation of d10: product id l-evolutfx-2329; product lot/serial number unknown; product type: compression loading system (cls) product id d-evolutfx-2329; product lot/serial number unknown; product type: delivery catheter system (dcs) 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: 19133748
• MDR Text Key: 340493065
• Report Number: 2025587-2024-02336
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370701
• UDI-Public: 00763000370701
• 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
• Report Date: 04/18/2024

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: 04/05/2024
• Initial Date FDA Received: 04/18/2024
• Date Device Manufactured: 02/03/2024
• 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
• Treatment: SEE H11...
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 81 KG