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

Model Number HTPV254252

Device Problem Gradient Increase (1270)

Patient Problems Foreign Body Reaction (1868); Pulmonary Valve Stenosis (2024)

Event Date 02/17/2022

Event Type  Injury  

Event Description

Medtronic received information that approximately one year following the implant of this transcatheter pulmonary bioprosthetic valve, the patient's mean pulmonary valve gradient was 46 millimeters of mercury (mmhg) which was an increase from 28 mmhg noted six months prior. An echocardiogram was performed and showed no pulmonary regurgitation or paravalvular leak. Stenosis with concentric narrowing of the midportion of the valve frame, prominent neointimal hyperplasia or pannus formation extending from the right ventricular outflow tract and encompassing the prosthetic valve leaflets was confirmed with computed tomography (ct). Approximately, one year and two months post valve implant a dilation with a 28 millimeter non-medtronic balloon followed by the implant of a second non-medtronic transcatheter pulmonary valve was performed. The post-intervention right ventricle to pulmonary artery (rv-pa) peak-to-peak gradient was 3 millimeters of mercury (mmhg). No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed. Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.

• Brand Name: HARMONY TRANSCATHETER PULMONIC 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13726350
• MDR Text Key: 289961142
• Report Number: 2025587-2022-00655
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/16/2021
• Device Model Number: HTPV254252
• Device Catalogue Number: HTPV254252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/16/2020
• 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: 03/10/2022 Patient Sequence Number: 1