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	No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Tachycardia (2095); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following the implant of the transcatheter bioprosthetic pulmonary valve, during the first postoperative night, runs of non-sustained ventricular tachycardia (nsvt) were observed.Treatment was not reported.However, hospitalization was required.Approximately 2 months following implant the nsvt was resolved.The physician indicated the nsvt was causally related to the delivery catheter system (dcs), valve, and implant procedure.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name harmony delivery catheter system; product id: harmony-dcs (lot: 0012663878); product type: 0195-heart valves; implant date na ; explant date na.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.
Additional Manufacturer Narrative
Additional information received showed there is no information to reasonably suggest the device in this report may have caused or co ntributed to a death or serious injury or malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.Updated data: b5.A second paragraph was added.B7.Relevant history was added.D10.The initial medwatch was submitted listing the dcs as a concomitant device to the reported event.H6.And additional codes.Were changed.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 following the implant of the transcatheter bioprosthetic pulmonary valve, during the first postoperative night, runs of non-sustained ventricular tachycardia (nsvt) were observed.Treatment was not reported.However, hospitalization was required.Approximately 2 months following implant the nsvt was resolved.The physician indicated the nsvt was causally related to the delivery catheter system (dcs), valve, and implant procedure.Additional information was received to report the patient's baseline medical history included pre-existing nsvt.The patient was not prescribed medication to treat the pre-existing nsvt; however, a beta-blocker (metoprolol) medication was initiated during admission as first-line treatment.The previously documented narrative was corrected to report the patient's hospitalization was not prolonged as a result of the observed nsvt.

• 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: 22976729
• Report Number: 9617601-2025-01324
• Device Sequence Number: 9391283
• Product Code: NPV
• UDI-Device Identifier: 00763000338992
• UDI-Public: (01)00763000338992(17)260206
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P200046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2025

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: 02/06/2026
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/04/2025
• Date Device Manufactured: 02/06/2025
• 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: NO
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White