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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 DELIVERED

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MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number PB 10
Device Problems Obstruction of Flow (2423); Incomplete Coaptation (2507)
Patient Problems Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Right Ventricular Hypertrophy (2056)
Event Date 09/01/2019
Event Type  Injury  
Manufacturer Narrative
Citation: jhaveri s et al. Hammock effect and complete cusp prolapse: rare mechanisms of melody valve failure demonstrated by intracardiac echocardiography. Ann pediatr cardiol. 2019 sep-dec; 12(3): 342¿344. Doi: 10. 4103/apc. Apc_143_18. Earliest date of publish used for event date (month and year valid). 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 two case reports in which intracardiac echocardiography identified unique complications associated with the melody valve. Patient 1: a (b)(6)-year-old male patient with a history of truncus arteriosus and truncal valve repair using a right ventricle to pulmonary artery homograft conduit. At age (b)(6), the patient had a 20 mm medtronic melody transcatheter pulmonary valve (serial number not provided) implanted in the existing homograft conduit due to severe conduit regurgitation with right ventricular dilation. After melody implant, mild residual stenosis was noted. Six years later, a transthoracic echocardiogram and cardiac magnetic resonance imaging showed severe pulmonary regurgitation with right ventricle dilation. An elective cardiac catheterization was performed. During the procedure, an intracardiac echocardiogram revealed complete prolapse of the melody valve leaflets without any coaptation causing severe regurgitation. Subsequently, a second melody valve (22 mm; serial number not provided) was implanted valve-in-valve. One-year later, it was reported that the function of the second melody valve was excellent. 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 DELIVERED
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
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key9507828
MDR Text Key172562299
Report Number2025587-2019-03862
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 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
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 Received12/03/2019
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: 12/20/2019 Patient Sequence Number: 1
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