MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV HARMONY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI

Model Number	HARMONY-25
Medical Device Problem Codes	Gradient Increase (1270); Patient Device Interaction Problem (4001); Thickening of Material (4056)
Health Effect - Clinical Codes	Bacterial Infection (1735); Diarrhea (1811); Endocarditis (1834); Fatigue (1849); Fever (1858); Tachycardia (2095); Chills (2191); Thromboembolism (2654); Transvalvular Pressure Gradient Increased (4854)
Date of Event	07/06/2026
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
It was reported that 3 years and 1 month following implantation of a transcatheter pulmonary valve, the patient presented to their primary care physician after developing fever, headache, fatigue, and diarrhea.The patient was prescribed an antibiotic and given return precautions.With the patient's symptoms not resolving, they presented to the emergency department.During this evaluation, lab work was obtained which reflected a white blood cell count of 23 × 10³ cells per microliter (× 10³/¿l), a hemoglobin of 10.2 grams per deciliter (g/dl), a platelet count of 223 thousands per microliter (k/¿l), and a white blood cell concentration of 93.6% neutrophils.The patient was also noted to have a fever, a tachycardic rate, and blood cultures positive for streptococcus species.A transthoracic echocardiogram (tte) was also obtained, which indicated pulmonary valve endocarditis, vegetations on the septal most leaflet of the pulmonary valve, and a perivalvular abscess.Subsequently, the patient was administered intravenous therapy (iv) antibiotics and transferred to a facility that could provide a higher level of care.Once transferred, an echocardiogram was obtained, which revealed thickened pulmonary valve leaflets and a pulmonary valve gradient of 48 millimeters of mercury (mmhg).A second echocardiogram was then obtained which indicated a small echogenic mass on the tip of the bioprosthetic pulmonary valve leaflet, as well as lucent collections on either side of the valve.Following completion of both echocardiograms, a computed tomography (ct) scan was completed which reflected vegetation throughout the bioprosthetic valve and bilateral pulmonary consolidations (greater on right side then left) of septic eboli in the right upper lobe, right middle lobe, and bilateral lower lobes.Subsequently, the bioprosthetic pulmonary valve was explanted and a non-medtronic surgical valve was implanted.

• Brand Name: HARMONY TRANSCATHETER PULMONARY VALVE
• Common Device Name: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• 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: 25862138
• Report Number: 9617601-2026-04441
• Device Sequence Number: 5167303
• Product Code: NPV
• UDI-Device Identifier: 00763000338992
• UDI-Public: (01)00763000338992(17)240327
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P200046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: HARMONY-25
• Device Catalogue Number: HARMONY-25
• 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: 07/14/2026
• Initial Report FDA Received Date: 07/17/2026
• Date Device Manufactured: 03/28/2023
• 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: 23 YR
• Patient Sex: Female
• Patient Weight: 55 KG