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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 Degraded (1153)
Patient Problems Pulmonary Valve Stenosis (2024); Obstruction/Occlusion (2422); Heart Failure/Congestive Heart Failure (4446); Pulmonary Valve Insufficiency/ Regurgitation (4452); Unspecified Heart Problem (4454)
Event Date 05/04/2019
Event Type  Injury  
Manufacturer Narrative
Citation: baird cw et al. Reintervention rates after bioprosthetic pulmonary valve replacement in patients younger than 30 years of age: a multicenter analysis. J thorac cardiovasc surg. 2020 sep 10;s0022-5223(20)32564-2. Doi: 10. 1016/j. Jtcvs. 2020. 06. 157. Read at the 99th annual meeting of the american association for thoracic surgery, toronto, ontario, canada, may 4-7, 2019. Earliest date of presentation 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 difference in time to and predictors of reintervention according to valve type after bioprosthetic pulmonary valve replacement in patients younger than 30 years of age. All data were retrospectively collected from eight centers between february 1996 and october 2016. The overall study population included 1,278 patients and was predominantly female. Of those, 47 patients were implanted with medtronic devices in the pulmonary position: hancock valved conduits or hancock ii bioprosthetic valves (32), mosaic bioprosthetic valves (5), freestyle bioprosthetic valves (3), and melody transcatheter pulmonary valves (7). No serial numbers were provided. Three patients treated with hancock conduits or hancock ii valves died during follow-up (mean duration of 6 years). The causes of the deaths were not characterized. Among all patients in the ¿other¿ valve type subgroup (mosaic, freestyle, melody, and non-medtronic porcine bioprosthetic valve), one death occurred at approximately 12 years and 9 months post-implant. The type of valve implanted in this patient was not disclosed. Based on the available information, medtronic product was not directly associated with these four deaths. Among all patients in the hancock and ¿other¿ valve type subgroups, adverse events included: mild to moderate pulmonary regurgitation, pulmonary stenosis, right ventricular dysfunction, and left ventricular dysfunction. Reasons for reintervention: pulmonary regurgitation (no hancock cases), pulmonary stenosis/right ventricular outflow tract obstruction, or structural valve dysfunction/deterioration. Reinterventions performed: surgical pulmonary valve replacement, transcatheter valve-in-valve replacement, or balloon dilation. The time from valve implant to reintervention ranged from approximately 7 to 14 years. 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 Key11167912
MDR Text Key227582999
Report Number2025587-2021-00168
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
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 Received12/18/2020
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: 01/13/2021 Patient Sequence Number: 1
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