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

Model Number	PB1016
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	03/24/2026
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 11 years and 8 months following the implant of a transcatheter pulmonary valve, infective endocarditis was identified.Subsequently, the patient was hospitalized and explant of the transcatheter pulmonary valve was planned as well as the implant of a new transcatheter pulmonary valve.Per the physician, the transcatheter pulmonary valve contributed to the patient's infective endocarditis.
Event or Problem Description
It was reported that 11 years and 8 months following the implant of a transcatheter pulmonary valve, infective endocarditis was identified.Subsequently, the patient was hospitalized and explant of the transcatheter pulmonary valve was planned as well as the implant of a new transcatheter pulmonary valve.Per the physician, the transcatheter pulmonary valve contributed to the patient's infective endocarditis.Additional information was received that the endocarditis was confirmed, and vegetation was present on echocardiogram.It was clarified that this transcatheter valve will be replaced with just a surgical pulmonary valve.There were no factors that would have predisposed the patient to endocarditis, and the patient does not have a history of endocarditis.
Additional Manufacturer Narrative
Additional information received shows that there is no information to reasonably suggest that the valve in this report may have caused or contributed to a death or serious injury or that the valve in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.Insufficient information was received to reasonably suggest the device caused/contributed to a reportable event.Valid scientific evidence supports no valve-related cause for endocarditis where the valve implant time exceeds two months.Ref: 21 cfr 803.20 (c)(2), and position paper: (b)(4): reporting rationale on infective endocarditis associated with prosthetic/bioprosthetic valves; annuloplasty devices.Updated data: b5, 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: MELODY 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: 24716461
• Report Number: 9617601-2026-02089
• Device Sequence Number: 5763212
• Product Code: NPV
• UDI-Device Identifier: 00643169415850
• UDI-Public: (01)00643169415850(17)160401
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P140017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 04/20/2026

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: 04/01/2016
• Device Model Number: PB1016
• Device Catalogue Number: PB1016
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 05/14/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 21 YR
• Patient Sex: Unknown
• Patient Weight: 83 KG