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

Model Number	HARMONY-DCS
Medical Device Problem Codes	Difficult to Advance (2920); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemodynamic instability (4868)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: harmony-dcs; lot #: 0012896884; product type: 0195-heart valves; implant date: non-implantable product id: harmony-25; serial #: (b)(6): product type: 0195-heart valves; implant date: attempted, never implanted.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, during the attempted implantation of this transcatheter pulmonary bioprosthetic valve (tpv), in a patient with tortuous anatomy and a small left pulmonary artery (lpa) acute angle, the torturous anatomy posed procedural challenges from the start of the case.After performing several atrial loop attempts to place the valve in the optimal position, the implant team did not feel it was safe to continue with the same delivery catheter system (dcs) and opted to use a second dcs.During the attempt to place thetpv in the optimal position, the patient¿s acute lpa angle contributed to hemodynamic instability.The system was subsequently withdrawn from the patient¿s body, and the procedure was aborted per the anesthesiologist¿s recommendation.No patient symptoms or complications were reported as a result of this product issue.
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
Additional information was received that the hemodynamic instability presented during the use of the first dcs in the patient.It was clarified that a new transcatheter valve was used with the second dcs.The dcs was difficult to advance through the patient's anatomy, and the deployment of the second valve was attempted with approximately 3 deployment attempts.The right pulmonary artery wire position was used during deployment.The valve was not resheathed during the attempted implant.No further intervention has been performed or scheduled.The patient was reported to be doing fine.Per the physician, the valve did not cause or contribute to the hemodynamic instability.

• 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: 24834927
• Report Number: 9612164-2026-01834
• Device Sequence Number: 21124301
• Product Code: NPV
• UDI-Device Identifier: 00763000341367
• UDI-Public: (01)00763000341367(17)270115(10)0013236643
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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 Model Number: HARMONY-DCS
• Device Catalogue Number: HARMONY-DCS
• Device Lot Number: 0013236643
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 01/15/2026
• 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
• Patient Age: 27 YR
• Patient Sex: Female