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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 Fracture (1260); Gradient Increase (1270); Obstruction of Flow (2423)
Patient Problems Endocarditis (1834); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)
Event Date 08/30/2019
Event Type  Injury  
Manufacturer Narrative
Citation: sadeghi s et al. Risk factors for infective endocarditis following transcatheter pulmonary valve replacement in patients with congenital heart disease. Catheter cardiovasc interv. 2019 oct 1;94(4):625-635. Doi: 10. 1002/ccd. 28474. Epub 2019 aug 30. Earliest date of publish used for event date. 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 the risk factors for infective endocarditis in patients who underwent transcatheter pulmonary valve replacement (tpvr). All data were retrospectively collected from a single center between october 2010 and october 2017. The study population included 235 patients and was predominantly male with a mean age of 22 years and a mean weight of 63 kg. Of those, 183 were implanted with medtronic melody transcatheter valves; 3 were previously implanted with medtronic hancock valved conduits; and 2 were previously implanted with medtronic mosaic surgical valves. No serial numbers were provided. It was reported that the median duration from transcatheter valve implant to onset of endocarditis was 3. 3 years (range 2 to 7. 2 years). Among all melody patients, 2 deaths were reported. The causes of death were due to septic shock (1) and cardiac arrest secondary to heart failure 1. 5 years after recurrent episode of endocarditis (1). Based on the available information, medtronic product was not directly associated with the deaths. Among all melody patients, adverse events included: severe pulmonary stenosis and/or stent fracture that required redo tpvr, bacterial endocarditis, surgical explant and replacement of the valve due to fungal endocarditis, valvular mobile mass and/or vegetations due to bacterial or fungal endocarditis, extracorporeal membrane oxygenation support, moderate-severe pulmonary regurgitation, and high peak/mean residual gradients. Based on the available information, medtronic product was associated with the adverse events. Among all hancock and mosaic patients, adverse events included: transcatheter valve-in-valve implantation. The reason for valve-in- valve implantation was not reported. Other adverse events observed: moderate-severe pulmonary regurgitation and high peak/mean gradients. 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
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key9526863
MDR Text Key187046938
Report Number2025587-2019-03900
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 Other Health Care Professional
Type of Report Initial
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
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 Received12/04/2019
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: 12/27/2019 Patient Sequence Number: 1
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