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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 PB 10
Device Problems Partial Blockage (1065); Gradient Increase (1270)
Patient Problems Endocarditis (1834); Pulmonary Valve Stenosis (2024)
Event Date 01/24/2022
Event Type  Injury  
Manufacturer Narrative
Citation: samayoa j. , et al. Echocardiographic assessment of melody versus sapien valves following transcatheter pulmonary valve replacement. Jacc cardiovasc interv. 2022 jan 24;15(2):165-175. Doi: 10. 1016/j. Jcin. 2021. 11. 002. Pmid: 35057987 earliest date of publish used for date of event. Medtronic products referenced: melody (pma# p140017, product code: npv). Earliest approved product used for product code and pma#. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without return of the product no definitive conclusion can be made regarding the clinical observations. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information via literature regarding the intermediate/mid-term performance of two competitor transcatheter pulmonary valves, based upon echocardiography. All data were retrospectively collected from a single center between 2011 and 2020. The study population included 328 pediatric and adult patients, with 202 of them implanted with medtronic melody bioprosthetic valves (predominantly male, mean age 14. 4 years, mean weight 49. 1 kg; unique device identifier numbers not provided). Among all medtronic melody patients, adverse events included: two cases of endocarditis with high transvalvular gradients and pulmonary stenosis (ps), requiring surgical explantation and pulmonary valve replacement. The timeline of endocarditis development was not reported within the article. Based on the available information medtronic product may have been associated with the adverse events. No further patient complications have been reported as a result of this event.
 
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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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13832098
MDR Text Key287585369
Report Number2025587-2022-00745
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 Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPB 10
Device Catalogue NumberPB 10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/20/2022 Patient Sequence Number: 1
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