MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV EVOLUT FX PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVFXPLUS-34
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that five years and five months following the implant of this transcatheter bioprosthetic valve, a failed valve was identified.The primary mode of valve failure was reported as structural valve dysfunction (svd), mixed aortic stenosis (as)/aortic regurgitation (ar) with moderate hemodynamic valve deterioration (hvd), specified as a new occurrence or increase of >=1 grade of intra-prosthetic ar resulting in >=moderate ar.It was noted that following the implant of this valve no paravalvular leak (pvl) observed.Two months and fifteen days later, a second medtronic transcatheter aortic valve (tav) was implanted valve-in-valve.Additional information confirmed that during the valve-in-valve (viv) procedure, a pre-ballooning of the pre-existing medtronic valve was performed.The medtronic replacement valve was then implanted.This new valve was reported to be in the correct position, both within the proper and desired anatomical location.A post-ballooning of this new, active medtronic valve was performed due to under expansion.The patient was discharged on the same date as the viv.
Additional Manufacturer Narrative
Continuation of d10: product id d-evolutfx-34; product lot/serial number (b)(6); product type: delivery catheter system; implant date n/a; explant date n/a product id l-evolutfx-34; product lot/serial number unknown; product type: compression loading system; implant date n/a; explant date n/a product id l-evolutfx-34; product lot/serial number d308153; product type: heart valve; implant date (b)(6) 2020; explant date n/a, product id non-medtronic extra stiff guidewire; product lot/serial number unknown; product type: guidewire; implant date n/a; explant date n/a.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 PLUS VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50061235
• Report Number: 9617601-2026-04676
• Device Sequence Number: 18813302
• Product Code: NPT
• UDI-Device Identifier: 00763000716158
• UDI-Public: (01)00763000716158(17)280217(20)01
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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
• Operator of Device: Health Professional
• Device Model Number: EVFXPLUS-34
• Device Catalogue Number: EVFXPLUS-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 09/26/2026; 09/28/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/30/2026; 09/30/2026
• Date Device Manufactured: 02/17/2026
• 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: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 258 LB
• Patient Race: White