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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 Fracture (1260)
Patient Problems Non specific EKG/ECG Changes (1817); Pulmonary Edema (2020); Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452)
Event Date 05/23/2017
Event Type  Injury  
Manufacturer Narrative
Citation: bensemlali m et al. Percutaneous pulmonary melody ® valve implantation in small conduits. Arch cardiovasc dis. 2017 oct;11 0(10):517-524. Doi: 10. 1016/j. Acvd. 2016. 12. 013. Epub 2017 may 23. 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 technical and clinical outcomes in patients who underwent percutaneous pulmonary valve implantation in right ventricular outflow tract (rvot) conduits less than or equal to 16 mm. All data were retrospectively collected from a single center between september 2000 and december 2015. The study population included 11 patients and was predominantly male with a median age of 15. 7 years and a median weight of 48 kg. The diameter of the rvot conduit was 12 mm in two patients, 14 mm in one patient, and 16 mm in eight patients. All patients were implanted with medtronic melody transcatheter pulmonary valves. No serial numbers were provided. Among all patients, reinterventions included: surgical pulmonary valve replacement due to recurrent stenosis with valve stent fractures, and percutaneous balloon dilation of the valve due to recurrent stenosis. The median reintervention time was 4. 3 years (range of 2. 2 to 6. 6 years). Additional adverse events included: temporary right ventricle pacing after valve implant, trivial pulmonary regurgitation, increased maximum velocity across the valve, hospitalization in the intensive care unit after valve implant due to severe acute pulmonary edema, and vascular access bleeding requiring prolonged compression. 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 Key11049866
MDR Text Key223615224
Report Number2025587-2020-03890
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeFR
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 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received12/03/2020
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: 12/21/2020 Patient Sequence Number: 1
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