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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 Gradient Increase (1270)
Patient Problems Endocarditis (1834); Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452); Unspecified Heart Problem (4454)
Event Date 12/11/2021
Event Type  Injury  
Manufacturer Narrative
Citation: davtyan a, et al. Selective valve removal for melody valve endocarditis: practice variations in a multicenter experience. Pediatr cardiol. 2021 dec 11. Doi: 10. 1007/s00246-021-02801-z. Earliest date of publish 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 from a literature article regarding the factors associated with surgical explantation versus antimicrobial therapy in patients with melody valve endocarditis. All data was retrospectively collected from four centers between october 2010 and march 2019. A total of 663 medtronic melody transcatheter pulmonary valves were implanted during the study period. Of these, 59 patients developed endocarditis and were included in the study population (predominantly male, median age 19. 5 years). Some patients had recurrence (second or third episode of endocarditis), resulting in a total of 66 cases of endocarditis. Of the 59 patients in the study population, four deaths occurred during endocarditis treatment. Causative organisms included: culture (b)(6): (b)(6), and cardiobacterium hominis. Time from melody valve implant to onset of endocarditis ranged between 2. 1 and 7. 5 years. Based on the time from melody valve implant to endocarditis, none of these deaths were related to the valve. One additional death occurred due to end-stage renal disease more than 1. 4 years after successful treatment of endocarditis and was stated to be unrelated to the melody valve. Of the 66 cases of endocarditis, 39 were treated with intravenous antimicrobials and 27 cases had the melody valve surgically explanted with concurrent antimicrobial therapy. Other interventions reported: transcatheter balloon valvuloplasty, and transcatheter valve-in-valve replacement after completing treatment for endocarditis. Median time from melody valve implant to onset of endocarditis was 2. 3 years (range, 1. 2 to 4. 6) for the valve not explanted group and 2. 8 years (range, 1. 7 to 5. 1) for the valve explanted group. Causative organisms included: streptococcal species, (b)(6), culture (b)(6)/unknown, hacek organisms, enterococcus species, bartonella henselae, other bacteria, and fungus. Reasons for melody valve explant included: stenosis, right ventricular dysfunction, severe regurgitation/insufficiency, vegetations, surgeon preference, concern for inadequate response to antimicrobials, and recurrent endocarditis. Increased right ventricular outflow tract gradients were also observed. Additionally, the authors reported that five of the 59 patients in the study population had a medtronic contegra valved conduit in place prior to melody valve implant, indicating these patients had undergone transcatheter valve-in-valve replacement (melody valve implanted inside contegra conduit). The reasons for replacement were not provided. No unique device identifier numbers were provided. 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 Key13500524
MDR Text Key289355467
Report Number2025587-2022-00399
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
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 Received01/11/2022
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: 02/09/2022 Patient Sequence Number: 1
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