MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI

Model Number	PB1018
Medical Device Problem Codes	Activation Failure (3270); Material Split, Cut or Torn (4008); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Pulmonary Valve Insufficiency/ Regurgitation (4452)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: concomitant medical devices in use during the event include: product id: {ens1018}; product serial/lot number: {unknown}; product type: {0195 - heart valves}; 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 pulmonary valve implant procedure, in a patient with a previously implanted surgical pulmonary valve, a pre-implant balloon dilation was completed due it being standard for the implanting physician.Following the post-implant balloon dilation, the delivery catheter system (dcs) was inserted into the patient.The valve was then deployed and fully implanted into the previously implanted surgical valve.A post implant balloon dilation was then completed.After the post implant balloon dilation, moderate central regurgitation was identified.Subsequently, the attending physician opted to implant a second transcatheter pulmonary valve into the previously implanted transcatheter pulmonary valve.A 30-minute procedural delay occurred due to the event.Per the physician, the post-implant dilation and passing over a sheath contributed to damage to the valve that led to the moderate central regurgitation.
Additional Manufacturer Narrative
Updated data: b5, h6.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 post-implant dilation was performed on the first valve 2 times because the physician wanted to further dilate the valve so there was no waist.The type of balloon used was a 22 mm and 23 mm non-compliant balloon.The inflation time was 3 seconds, and the inflation device used was an in deflator.The inflation pressure was 8 ¿atm¿.It was noted that leaflet damage was observed after the post implant dilation.
Additional Manufacturer Narrative
Updated data: b2.B5.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
Additional information was received to clarify that the inflation pressure was 8 atmospheres (atm).As the valve was not explanted, the type of leaflet damage is unknown; however, it was suspected to be a torn leaflet.

• Brand Name: MELODY 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: 24837348
• Report Number: 9617601-2026-02386
• Device Sequence Number: 15758638
• Product Code: NPV
• UDI-Device Identifier: 00643169588196
• UDI-Public: (01)00643169588196(17)270822
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 04/09/2026; 04/29/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/29/2026; 05/19/2026
• Date Device Manufactured: 08/22/2025
• 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: SEE H11 ...
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 25 YR
• Patient Sex: Female