MAUDE Adverse Event Report: MEDTRONIC IRELAND HARMONY DELIVERY CATHETER SYSTEM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI

Model Number	HARMONY-DCS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemoptysis (1887); Low Blood Pressure/ Hypotension (1914); Great Vessel Perforation (2152)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id: harmony-25, serial/lot #: (b)(6), ubd: 25-feb-2027, udi#: (b)(4).The codes present in section h6.Correspond to multiple components/products that comprise this reported event.Select patient information cannot be included in the regulatory report due to regional privacy regulations.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 a transcatheter pulmonic valve, hemoptysis, a decrease in spo2, and a decrease in blood pressure were confirmed due to a right pulmonary artery perforation.Subsequently, 4 millimeter (mm) and 6 mm plugs were implanted, and veno-arterial extracorporeal membrane oxygenation (ecmo) was initiated.Subsequently, the bleeding resolved and the patient was returned to the room.
Additional Manufacturer Narrative
H6.Annex e code was erroneously omitted from the initial medwatch.Additional codes.Annex f code was erroneously omitted from the initial medwatch.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
Additional information was received that this was a case with the goal of implanting the transcatheter pulmonary valve in the roof of bifurcation (rob).During the procedure, hemostasis was completed, and the patient was returned to the room with veno-arterial ecmo.It was noted that the ecmo was initiated solely as an aid to remove carbon dioxide (co2), and the patient was considered to have few hemodynamic problems.Per the physician, the cause of the right pulmonary artery perforation was considered to be from pushing the guidewire when the guidewire tip was fixed within the peripheral vessel.
Event or Problem Description
Additional information was received that per the physician, neither the valve nor the delivery catheter system caused or contributed to the injury.Additionally, tortuosity of the peripheral pulmonary artery vessels contributed to the injury.The perforation occurred at the time of the non-medtronic guidewire removal.
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.

• Brand Name: HARMONY DELIVERY CATHETER SYSTEM
• Common Device Name: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 25209374
• Report Number: 9612164-2026-02572
• Device Sequence Number: 10390945
• Product Code: NPV
• UDI-Device Identifier: 00763000341367
• UDI-Public: (01)00763000341367(17)260819(10)0012976400
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2026

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: 08/19/2026
• Device Model Number: HARMONY-DCS
• Device Catalogue Number: HARMONY-DCS
• Device Lot Number: 0012976400
• 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: 05/15/2026
• Supplement Date Received by Manufacturer: 05/18/2026; 05/29/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 05/20/2026; 06/25/2026
• Date Device Manufactured: 08/19/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown