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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI Back to Search Results
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.
 
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Brand NameMELODY TRANSCATHETER PULMONARY 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12927332
MDR Text Key281746041
Report Number2025587-2021-03657
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140017
Number of Events Reported1
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 Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/09/2016
Device Model NumberPB1016
Device Catalogue NumberPB1016
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/24/2014
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
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