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

Model Number	HARMONY-DCS
Medical Device Problem Codes	Product Quality Problem (1506); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a transcatheter valve replacement procedure involving a pulmonary bioprosthetic valve, there were positioning difficulties during deployment, and the distal strut backfolded when the valve was unsheathed.Subsequently, the valve was recaptured using the introducer sheath and delivery catheter system (dcs) and withdrawn from the patient.A new valve was used to complete the procedure.The patient's tortuous anatomy contributed to these issues and the procedure was delayed by approximately 30 minutes.It was reported that the right pulmonary artery wire position was used during deployment.No patient complications have been reported as a result of this event.Additional information was received that during the loading process of the second valve and dcs, an actuator separation was noted.There was a delay of 8 minutes due to the dcs issues.
Additional Manufacturer Narrative
Continuation of d10: product id harmony-25 (sn: unknown); product type: 0195-heart valves; implant date n/a; explant date n/a.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
Updated data: b5.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 a different dcs was used for implant.
Additional Manufacturer Narrative
Corrected data: additional review of the event showed no information to reasonably suggest the device in this report may have caused or contributed to a death or serious injury or that the device malfunction in this report has caused or has the potential to cause death or serious injury if it were to recur.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.H6.Additional codes.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 during a transcatheter valve replacement procedure involving a pulmonary bioprosthetic valve, there were positioning difficulties during deployment, and the distal strut backfolded when the valve was unsheathed.Subsequently, the valve was recaptured using the introducer sheath and delivery catheter system (dcs) and withdrawn from the patient.A new valve was used to complete the procedure.The patient's tortuous anatomy contributed to these issues and the procedure was delayed by approximately 30 minutes.It was reported that the right pulmonary artery wire position was used during deployment.No patient complications have been reported as a result of this event.Additional information was received that during the loading process of the second valve and dcs, an actuator separation was noted.There was a delay of 8 minutes due to the dcs issues.Additional information was received that a different dcs was used for implant.

• Brand Name: HARMONY DELIVERY CATHETER SYSTEM
• 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: 21171805
• Report Number: 2025587-2025-00448
• Device Sequence Number: 11831291
• Product Code: NPV
• UDI-Device Identifier: 00763000341367
• UDI-Public: (01)00763000341367(17)250918(10)0012449273
• 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
• 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,Followup
• Report Date (Section B): 07/30/2025

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: 09/18/2025
• Device Model Number: HARMONY-DCS
• Device Catalogue Number: HARMONY-DCS
• Device Lot Number: 0012449273
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 01/16/2025; 07/30/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/06/2025; 07/30/2025
• Date Device Manufactured: 09/18/2024
• 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: SEE H11...
• Patient Age: 38 YR
• Patient Sex: Male