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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); High Blood Pressure/ Hypertension (1908); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)
Event Date 03/09/2018
Event Type  Injury  
Manufacturer Narrative
Citation: malekzadeh-milani s et al. French national survey on infective endocarditis and the melody valve in percutaneous pulmonary valve implantation. Arch cardiovasc dis. (b)(6) 2018. Pii: s1875-2136(18)30026-3. Doi: 10. 1016/j. Acvd. 2017. 10. 007. Earliest date of e-publish/publish used for event date. No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.     if information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information via literature regarding a french national survey on infective endocarditis and the melody valve in percutaneous pulmonary valve implantation.  all data were collected from multiple centers between 2008 and 2016.  the study population included 43 patients (predominantly male; mean age 26 years), 5 of which were initially implanted with medtronic hancock, 11 of which were initially implanted with medtronic contegra, and 43 of which were implanted with medtronic melody valves valve-in-valve (serial numbers not provided).   among all patients implanted with the hancock conduit, adverse events included: stenosis, regurgitation, and an increased gradient of 43 mmhg, requiring a valve-in-valve implant. Based on the available information, the stenosis, regurgitation, and increased gradient were attributed to medtronic product. Among all patients implanted with the contegra conduit, adverse events included: stenosis, regurgitation, and increased gradient of 43 mmhg, requiring a valve-in-valve implant. Endocarditis was also reported five years following the implant.  based on the available information, the stenosis, regurgitation, and increased gradient were attributed to medtronic product. Among all patients implanted with the melody transcatheter pulmonary bioprosthetic valve (tpbv), adverse events included: endocarditis, pulmonary hypertension, increased gradient, pulmonary regurgitation, and right ventricular outflow tract (rvot) obstruction requiring a surgical or percutaneous intervention. No additional adverse patient effects 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 Key7422842
MDR Text Key105204464
Report Number2025587-2018-00839
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 foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
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 Received04/09/2018
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: 04/11/2018 Patient Sequence Number: 1
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