MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVOLUTPRO-29-US
Medical Device Problem Codes	Gradient Increase (1270); Insufficient Device Problem Information (3190); Activation Failure (3270); Patient Device Interaction Problem (4001); Thickening of Material (4056); Unspecified Valve Regurgitation (4080)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580); Transvalvular Pressure Gradient Increased (4854)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 6 years and 11 months following the implant of a transcatheter aortic valve, an unspecified valve failure occurred.
Additional Manufacturer Narrative
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 6 years and 11 months following the implant of a transcatheter aortic valve, an unspecified valve failure occurred.Additional information was received that during the implant procedure and following the implant of the valve, an aortic angiography was performed that showed excellent deployment of the transcatheter valve with no paravalvular leak (pvl).However, an echocardiogram was performed that revealed a mean gradient of approximately 30 millimeters of mercury (mm hg).Subsequently, a spacing wire and pigtail catheter were used to cross the valve, and confirmed the patient had an increased gradient.Additionally, fluoroscopy revealed the valve appeared elliptically shaped.Therefore, a post-implant balloon aortic valvuloplasty (bav) was performed using a 24 millimeter (mm) non-medtronic balloon under rapid ventricular pacing to dilate the valve.A repeat aortic angiography was performed that showed no evidence of complications, and repeat echocardiogram showed a mean gradient of 3-6 mm hg.There were no conduction abnormalities, the pacer was removed, and the procedure was completed.Approximately 6 years and 11 months following the implant of this valve, the mechanism of failure was aortic insufficiency of unspecified severity.A computed tomography (ct) scan was performed that also revealed possible thrombus/pannus formation inside of the valve frame.Subsequently, the patient was admitted to the hospital for internal bleeding that was unrelated to the valve.It was planned for the patient to receive a new aortic valve (undetermined as to which valve), and the patient was stabilized.Approximately 2 weeks later, the patient went home to hospice.
Additional Manufacturer Narrative
Updated data: b1.B2.B3.B5.A second paragraph was added.H1.The original information indicated the event was a reportable malfunction.Additional information indicates that intervention was required.The event is now a reportable serious injury.H6.Additional codes.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 PRO TRANSCATHETER AORTIC 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 ; 091708096
• MDR Report Key: 24866975
• Report Number: 9617601-2026-02442
• Device Sequence Number: 13105542
• Product Code: NPT
• UDI-Device Identifier: 00763000017835
• UDI-Public: (01)00763000017835(17)201009
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 05/04/2026

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 Expiration Date: 10/09/2020
• Device Model Number: EVOLUTPRO-29-US
• Device Catalogue Number: EVOLUTPRO-29-US
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/04/2026
• Date Device Manufactured: 10/26/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female