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

Model Number EVOLUTFX-26

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Non specific EKG/ECG Changes (1817); Valvular Insufficiency/ Regurgitation (4449)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id l-evolutfx-2329 (lot: 0011827949); product type: 0195-heart valves; implant date ; explant date section d references the main component of the system.Other medical products in use during the event include: brand name evolut fx dcs; product id d-evolutfx-2329 (lot: 0011784873); product type: 0195-heart valves.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 implant of this transcatheter bioprosthetic valve, the patient had heavy calcification that continued to the left ventricular outflow tract (lvot) from the n-l commissure, therefore care was taken to select a safe size for balloon aortic valvuloplasty (bav).Upon first deployment attempt, the valve dislodged and was recaptured. upon second deployment attempt, when the valve deployed a little deeper, the pig tail catheter became stuck during recapture, therefore time was taken to pull the system into the ascending aorta to readjust it. on the third deployment attempt, the valve was placed however the patient had an atrio-ventricular block (avb), so the procedure was continued with temporary pacing. quite a lot of paravalvular leak (pvl) remained after valve placement therefore a post-implant bav was performed twice, with 18mm and 20mm balloons.Moderate pvl remained. the pressure gradient was reduced from 62mmhg to 7mmhg.The avb did not resolve by the time the patient returned to the intensive care unit (icu), so the patient left the operating room with temporary pacing.No adverse patient effects were reported.

Manufacturer Narrative

Updated b.5.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 a pre-balloon aortic valvuloplasty (bav) was performed with an 18 millimeter (mm) non-medtr onic balloon.The deployment starting point was at the bottom of the pigtail catheter.The first deployment attempt, the valve dislodged to the ascending aorta side.During the second deployment attempt, the deployment depth was a little deeper.When attempting to pass the system through the aortic valve, the pigtail catheter moved to the left ventricular side and became stuck.The valve was recaptured to eliminate interference with the pigtail catheter.It took time for the blood pressure to return to normal on the ascending side.The third deployment, the valve was deployed at a depth of 4 mm on the non-coronary cusp (ncc) and 5 mm on the left coronary cusp (lcc).

• 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: 19030807
• MDR Text Key: 339212941
• Report Number: 2025587-2024-02062
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTFX-26
• Device Catalogue Number: EVOLUTFX-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Date Device Manufactured: 07/29/2023
• 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): Hospitalization