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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 Gradient Increase (1270)
Patient Problems Endocarditis (1834); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)
Event Date 06/12/2019
Event Type  Injury  
Manufacturer Narrative
Citation: georgiev s et al. A low residual pressure gradient yields excellent long-term outcome after percutaneous pulmonary valve implantation. Jacc: cardiovascular interventions. 2019; 12(16):1594-1603. Doi: 10. 1016/j. Jcin. 2019. 03. 037. 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 a prospective study into the long-term effectiveness of percutaneous pulmonary valve implants (ppvi). All data were collected from a single center between december 2006 and december 2017. The study population included 226 patients (unknown male/female distribution, median age 18 years, median weight 59kg), 220 of which were implanted with medtronic melody ppvis, 17 with medtronic contegra conduits, and 12 with medtronic hancock conduits (no serial numbers provided). Among all patients, 7 deaths occurred. Two of the deaths occurred from procedure-related complications, one from conduit rupture leading to severe bleeding and one from left coronary artery compression. One death occurred at 8 months post implant of the ppvi, likely due to a rhythm disturbance caused by low potassium levels. Four deaths occurred at 3 years to 7 years post implant of the ppvi for unknown reasons but possibly due to rhythm disturbances. No further details about the deaths were provided, and multiple manufacturer¿s products were mentioned in the literature. Based on the available information medtronic product was not directly associated with the deaths. Among all medtronic melody patients, adverse events included: infective endocarditis, valve degeneration (stenosis), severe pulmonary regurgitation, elevated gradients. A total of 17 patients required intervention to replace the ppvi. Based on the available information medtronic product was directly 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 Key9617826
MDR Text Key176383762
Report Number2025587-2020-00238
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 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
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 Received01/09/2020
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: 01/22/2020 Patient Sequence Number: 1
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