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

Model Number	D-EVOLUTFX-34
Medical Device Problem Codes	Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Valvular Insufficiency/ Regurgitation (4449)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the implant of a transcatheter valve, a pre-implant balloon aortic valvuloplasty (bav) was performed due to a bicuspid aortic valve.During the deployment of the valve, the valve dislodged.Subsequently, a post-implant balloon aortic valvuloplasty (bav) was performed, and a trace leak occurred.Approximately 16 days following the implant of the transcatheter valve, the patient was hospitalized and an echocardiogram (tte) was performed, which revealed the valve had failed due to a severe paravalvular leak (pvl) and had migrated, causing severe circumferential aortic insufficiency (ai).Per the physician, the depth of the implant contributed to the event.
Additional Manufacturer Narrative
Continuation of d10: product id: evfxplus-34 (k069135); product type: 0195-heart valves; implant date: (b)(6) 2025; 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 or Problem Description
It was reported that prior to the implant of a transcatheter valve, a pre-implant balloon aortic valvuloplasty (bav) was performed due to a bicuspid aortic valve.During the deployment of the valve, the valve dislodged.Subsequently, a post-implant balloon aortic valvuloplasty (bav) was performed, and a trace leak occurred.Approximately 16 days following the implant of the transcatheter valve, the patient was hospitalized and an echocardiogram (tte) was performed, which revealed the valve had failed due to a severe paravalvular leak (pvl) and had migrated, causing severe circumferential aortic insufficiency (ai).Per the physician, the depth of the implant contributed to the event.Additional information was received indicating that during the procedure trace pvl was observed.The valve was initially implanted at a depth of 4 mm on the non-coronary cusp (ncc) and 4 mm on the left coronary cusp (lcc), but it dislodged ventricular to 10 mm on the ncc and 11 mm on the lcc.This dislodge occurred after full deployment was complete.
Additional Manufacturer Narrative
Additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.Updated data: b2.B5.Added second paragraph.D4.H4.H6.H11.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.
Additional Manufacturer Narrative
Corrected data h6.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 DCS
• Common Device Name: 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: 22177760
• Report Number: 2025587-2025-04157
• Device Sequence Number: 7789132
• Product Code: NPT
• UDI-Device Identifier: 00763000365684
• UDI-Public: (01)00763000365684(17)260715(10)0012358638
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2026
• Device Model Number: D-EVOLUTFX-34
• Device Catalogue Number: D-EVOLUTFX-34
• Device Lot Number: 0012358638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 08/04/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/14/2025; 08/04/2025
• Date Device Manufactured: 07/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female