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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 Problem Insufficient Information (3190)
Patient Problems Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452); Unspecified Heart Problem (4454)
Event Date 08/30/2019
Event Type  Injury  
Manufacturer Narrative
Citation: lehner a et al. Intermediate outcomes of transcatheter pulmonary valve replacement with the edwards sapien 3 valve ¿ german experience. Expert rev med devices. 2019 sep;16(9):829-834. Doi: 10. 1080/17434440. 2019. 1653180. Epub 2019 aug 30. 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 procedural and intermediate patient outcomes following transcatheter pulmonary valve replacement (tpvr) using a specific type of non-medtronic transcatheter valve. All data were retrospectively collected from seven centers between 2015 and 2017. The study population included 56 patients and was predominantly female with a mean age of 25 years and a mean weight of 59 kg. Of those, 16 patients were previously implanted with medtronic contegra valved conduits and an undisclosed number of patients were previously implanted with medtronic melody transcatheter pulmonary valves. No serial numbers were provided. Among all patients, adverse events included: tpvr (valve-in-conduit or valve-in-valve) due to pulmonary stenosis, pulmonary regurgitation, combination of both stenosis and regurgitation (gradient greater than or equal to 20 mmhg and moderate to severe regurgitation), or right ventricular dysfunction. In addition, conversion from tpvr to surgical pulmonary valve implantation was necessary in two cases. Based on the available information, medtronic product was associated with the adverse events. 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11021063
MDR Text Key221821797
Report Number2025587-2020-03832
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P140017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
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 Received12/02/2020
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: 12/16/2020 Patient Sequence Number: 1
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