MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB1016

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Mitral Regurgitation (1964); Pulmonary Valve Stenosis (2024)

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device was discarded, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that ten months and twenty-four days after the implant of this transcatheter bioprosthetic pulmonary valve, into a previously placed conduit, the valve and conduit were explanted and replaced surgically with a medtronic valve.Prior to the explant, cardiac catheterization revealed a right ventricular outflow tract (rvot) pressure gradient of 30 mm hg, rvot stenosis and moderate mitral regurgitation (mr).A decrease in activity level was also reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information was provided which indicated that per the physician, the conduit revision was performed due to subvalvar obstruction related to fibrous infundibulum ridge formation.Per the physician, the melody valve was not stenotic and was functioning well.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8150674
• MDR Text Key: 129906990
• Report Number: 2025587-2018-03376
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00643169415850
• UDI-Public: 00643169415850
• Combination Product (y/n): N
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2016
• Device Model Number: PB1016
• Device Catalogue Number: PB1016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 23