MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTEGRA; PULMONIC VALVED CONDUIT

Model Number	200SH18
Medical Device Problem Codes	Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 6 years and 5 months post implant of this 18mm contegra pulmonary valved conduit implanted in a then 8 year old pediatric patient, a transcatheter pulmonary bioprosthetic valve (tpbv) was implanted valve-in-valve.The reason for replacement was reported as free pulmonary regurgitation, moderate pulmonary stenosis and a high gradient of 40mmhg.The patient underwent a stepwise conduit rehabilitation procedure.A baseline aortic and right ventricle angiography were performed, confirming free pulmonary regurgitation and the pressure gradient.Serial dilation was conducted with atlas gold balloons in 2mm increments from 12mm up to 20mm, with no conduit injury noted.A 4.5cm cp covered stent was preemptively placed, followed by further dilation up to22mm and placement of a palmaz xl 4010 stent.Post-dilation was performed with a 24mm balloon.The gradient was reduced to 8mmhg, and a melody transcatheter valve was placed without issue.Final imaging showed a gradient of 0mmhg with no pulmonary regurgitation or paravalvular leak.No additional adverse patient effects were reported.
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 reason for replacement was due to outgrowth of the original conduit.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that changed the event description and device relatedness of this previously reported event.There was no evidence to suggest the device caused or contributed to a serious injury.B5 and h6 updated.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: CONTEGRA
• Common Device Name: PULMONIC VALVED CONDUIT
• 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: 24672704
• Report Number: 2025587-2026-00321
• Device Sequence Number: 10139754
• Product Code: MWH
• UDI-Device Identifier: 00643169616868
• UDI-Public: (01)00643169616868(17)220722
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/17/2026

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 Expiration Date: 07/22/2022
• Device Model Number: 200SH18
• Device Catalogue Number: 200SH18
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 08/21/2019
• 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; Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 52 KG