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

Model Number PB1016

Device Problems Gradient Increase (1270); Mechanical Problem (1384)

Patient Problems Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452); Pulmonary Hypertension (4460)

Event Date 03/01/2021

Event Type  Injury  

Event Description

Medtronic received information that approximately six years and two months following the implant of this transcatheter bioprosthetic pulmonary valve, the valve was re-dilated as a result of pulmonary stenosis. Valve stenosis and moderate pulmonary regurgitation (pr) with a gradient across the valve were reported. Approximately six years and eleven months following the valve implant, increased right ventricle pressures, reported as 3/4 the systemic pressure, moderate pr and a gradient of 30 millimeters of mercury (mmhg) across the pulmonary valve were reported. A palmaz stent and new melody valve were implanted. No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: no product was returned. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. Of note, date of event is an approximation. The exact date of the re-dilation was not reported. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received that outgrowth was potentially a factor in the replacement, however the physician could not be certain. 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 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12927332
• MDR Text Key: 281746041
• Report Number: 2025587-2021-03657
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/09/2016
• Device Model Number: PB1016
• Device Catalogue Number: PB1016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/03/2021 Patient Sequence Number: 1