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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 Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452)
Event Date 07/09/2021
Event Type  Injury  
Manufacturer Narrative
Citation: o¿callaghan b, et al. Contrast-free percutaneous pulmonary valve replacement: a safe approach for valve-in-valve procedures. Advances in interventional cardiology. 2021 jun;17(2):200-209. Doi: 10. 5114/aic. 2021. 107500. Epub: 2021 jul 9. 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 patient outcomes following contrast-free percutaneous pulmonary valve replacement (ppvi). The authors retrospectively collected ppvi data from the preceding two years (approximately 2018 to 2020) at a single center. The study population included 21 patients (predominantly female; median age 27 years; mean weight 69. 6 kg). One patient was previously implanted with a 27 mm medtronic mosaic bioprosthetic valve in the pulmonary position. Two patients were implanted with medtronic melody transcatheter pulmonary valves. Of these two patients, one was previously implanted with a 22 mm melody inside a pulmonary homograft, and the other patient underwent contrast-free implantation of an 18 mm melody within a 21 mm sorin mitroflow valve. No unique device identifier numbers were provided. The mosaic patient underwent ppvi (transcatheter valve-in-valve replacement) with an edwards sapien 3 bioprosthesis. The patient previously implanted with a 22 mm melody underwent ppvi (transcatheter valve-in-valve replacement) with an edwards sapien 3 bioprosthesis. The authors noted the mean time from bioprosthetic valve implantation to ppvi was 8. 5 years (range of 6 to 17 years) and the cause of valve dysfunction was isolated stenosis or mixed stenosis and regurgitation. Elevated pressure gradients were also observed before ppvi. No patient had more than trivial pulmonary incompetence after ppvi. No additional adverse patient effects or product performance issues associated with medtronic product 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 Key12800336
MDR Text Key280761079
Report Number2025587-2021-03421
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 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2021
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
Date Manufacturer Received10/14/2021
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: 11/11/2021 Patient Sequence Number: 1
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