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

Model Number	EVOLUTR-34-US
Medical Device Problem Codes	Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Pleural Effusion (2010); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
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
Medtronic received information that following the implant of this 34mm transcatheter bioprosthetic valve, echocardiography showed trace paravalvular leak and trace central aortic regurgitation.No treatment was reported.Forty-three days following valve implant, a 12-lead electrocardiogram showed normal sinus rhythm with first degree atrio-ventricular block.No treatment was provided.No adverse patient effects were reported.Additional information received indicated that approximately 6 years and 3 months following the implant of the transcatheter aortic valve an echocardiogram identified mild aortic insufficiency.Approximately 1.5 months later the patient was seen as an outpatient and an echocardiogram identified an ejection fraction of 65-70%.Small to moderate pleural effusions and at least moderate aortic insufficiency were identified.Mild mitral regurgitation and mild tricuspid regurgitation were also present.The following day the patient was admitted to the hospital for acute heart failure with decompensation in the setting of severe bioprosthetic aortic insufficiency.An elevated troponin level occurred.Medication was administered.Two days later an echocardiogram and computed tomography angiogram (cta) were performed.The non-coronary cusp (ncc) was reported as ¿flail¿.The physician indicated the event was causal related to the transcatheter valve.Seven days later the transcatheter valve was explanted and an unspecified surgical valve was implanted.A left atrial appendate clip ligation performed due to episodes of atrial fibrillation upon induction.A permanent pacemaker wa s implanted 7 days following the surgical valve implant due to complete heart block.The transcatheter valve aortic regurgitation event was reported as recovering.

• Brand Name: EVOLUT R 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: 24438279
• Report Number: 9617601-2026-01418
• Device Sequence Number: 10364295
• Product Code: NPT
• UDI-Device Identifier: 00763000017682
• UDI-Public: (01)00763000017682(17)210527
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted 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
• Report Date (Section B): 02/24/2026

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: 05/27/2021
• Device Model Number: EVOLUTR-34-US
• Device Catalogue Number: EVOLUTR-34-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: 01/28/2026
• Initial Report FDA Received Date: 02/24/2026
• Date Device Manufactured: 06/13/2019
• 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; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White