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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 Problem Patient Device Interaction Problem (4001)
Patient Problems Endocarditis (1834); Pulmonary Valve Stenosis (2024)
Event Date 09/08/2020
Event Type  Injury  
Manufacturer Narrative
Citation: davtyan et al. Melody endocarditis does not equal valve removal: variations in practice in a multicenter experience. Pediatr cardiol. 2020, 41:1248¿1298. Pics-aics 2020-pediatric and adult interventional cardiac symposium from 8 sep 2020 thru 11 sep 2020. Earliest date of conference used for date of event. 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 antibiotic therapy for endocarditis following implant of a melody bioprosthetic valve. All data were collected from four united states centers from 2010 to 2019. The study population included 666 patients (demographic information not provided), all of which were implanted with a medtronic melody bioprosthetic valve (unique device identifier numbers not provided). During a mean follow-up period of 2. 9 years, 61 patients had endocarditis and 33 of those patients were treated medicinally with success. Two patients had recurrent endocarditis, one of which was treated medicinally and one which required surgery to explant the valve. Other valve explants were performed due to stenosis with or without right ventricular dysfunction, concern for inadequate response to antibiotics, and surgeon preference. Based on the available information medtronic product may have been associated with the adverse event(s). No additional adverse patient effects or product performance issues were reported.
 
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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 Key12516579
MDR Text Key272915393
Report Number2025587-2021-02866
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,literatur
Reporter Occupation
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
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: 09/22/2021 Patient Sequence Number: 1
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