• 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 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

  • 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 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number PB1016
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Pulmonary Valve Stenosis (2024); No Information (3190)
Event Date 08/04/2020
Event Type  Injury  
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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that approximately five years, five months and sixteen days following the implant of this transcatheter pulmonary bioprosthetic valve, the valve was surgically explanted and replaced with a medtronic surgical valve. The reason for explant and replacement was not reported. No additional adverse patient effects were reported.  .
 
Manufacturer Narrative
Additional information was received that the valve was explanted due to stenosis. No additional adverse patient effects were reported.   product analysis: the device was discarded, therefore no product analysis can be performed. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMELODY TRANSCATHETER PULMONARY VALVE
Type of DevicePULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key10579901
MDR Text Key208324040
Report Number2025587-2020-02917
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
PMA/PMN Number
P140017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/06/2016
Device Model NumberPB1016
Device Catalogue NumberPB1016
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/24/2020 Patient Sequence Number: 1
-
-