• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC HEART VALVES DIVISION HARMONY TRANSCATHETER PULMONIC VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHARMONY TRANSCATHETER PULMONIC VALVE
Type of DevicePULMONARY 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 Key13726350
MDR Text Key289961142
Report Number2025587-2022-00655
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P200046
Number of Events Reported1
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 Received03/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/16/2021
Device Model NumberHTPV254252
Device Catalogue NumberHTPV254252
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/16/2020
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
-
-