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

Model Number EVOLUTFX-26

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

Patient Problem Heart Block (4444)

Event Date 03/19/2024

Event Type  Injury  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the valve dislodged into the ascending aorta and was recaptured.Upon final full release, intrinsic rhythm was confirmed at a heart rate (hr) of 40 units, and a complete atrio-ventricular (av) block was confirmed.The patient left the operating room under pacing.No additional adverse patient effectswere reported.

Manufacturer Narrative

Continuation of d10: product id l-evolutfx-2329 (lot: 0011866455); product type: 0195-heart valves; 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: 0011956740); 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.

Manufacturer Narrative

Updated data: b5.Second paragraph.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.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 valve dislodged into the ascending aorta and was recaptured.Upon final full release, intrinsic rhythm was confirmed at a heart rate (hr) of 40 units, and a complete atrio-ventricular (av) block was confirmed.The patient left the operating room under pacing.No additional adverse patient effectswere reported.Additional information was received to report a pre-implant balloon dilatation was not performed; however, a post-implant balloon aortic valvuloplasty was performed due to severe calcification.During the first deployment attempt, the deployment starting point was at the bottom of the pigtail catheter, but the position of the valve was deep and the valve was recaptured.The valve dislodged during the second deployment attempt.Upon final release, the implant depth was 3mm on the non-coronary cusp and 6mm on the left coronary cusp.It was confirmed a permanent pacemaker was not implanted.

• 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: 18986960
• MDR Text Key: 338716447
• Report Number: 2025587-2024-01936
• 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: 05/24/2024

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?: Yes
• 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
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/24/2024
• Date Device Manufactured: 08/12/2023
• 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