MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HARMONY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI

Model Number	HARMONY-22
Medical Device Problem Codes	Gradient Increase (1270); Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.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 during implant of this transcatheter pulmonary bioprosthetic valve, the valve was implanted in the recommended landing zone.Buckling was then observed on struts 4-5, likely due to the horizontal nature of the patient's anatomy.Per the physician, the valve was conforming to the patient's anatomy but the mid pulmonary artery had a curved anatomy and the valve could not take the curve.A gradient of 50 millimeters of mercury (mmhg) was recorded.A post- balloon assist was performed with a 24 millimeter (mm) non-medtronic balloon.Due to the balloon assist, the valve repositioned and the buckling of the struts resolved.Subsequently, the gradient decreased to 8mmhg, which was similar to the patient's pre-operation measurement (3 mmhg).An angiogram was performed and no paravalvular leak (pvl) was observed.An intracardiac echocardiogram (ice) was performed, confirming the proper function of the valve leaflets.It was reported that the physician was happy with the device performance following the balloon dilation.Per the physician, the frame distortion was caused by the patient's anatomy.No additional adverse patient effects were reported.

• Brand Name: HARMONY TRANSCATHETER PULMONARY VALVE
• Common Device Name: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21103105
• Report Number: 2025587-2025-00178
• Device Sequence Number: 9161306
• Product Code: NPV
• UDI-Device Identifier: 00763000338985
• UDI-Public: 00763000338985
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P200046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2023
• Device Model Number: HARMONY-22
• Device Catalogue Number: HARMONY-22
• 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: 04/04/2023
• Initial Report FDA Received Date: 01/08/2025
• Date Device Manufactured: 12/06/2022
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 60 KG