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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 Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Patient Problems Low Blood Pressure/ Hypotension (1914); Pulmonary Valve Stenosis (2024); Cardiovascular Insufficiency (4445); Pulmonary Valve Insufficiency/ Regurgitation (4452)
Event Date 11/09/2011
Event Type  Injury  
Manufacturer Narrative
Citation: hasan et al. Short-term performance of the transcatheter melody valve in high-pressure hemodynamic environments in the pulmonary and systemic circulations. Circ cardiovasc interv. 2011 dec 1; 4(6):615-20. Doi: 10. 1161/circinterventions. 111. 963389. Epub: (b)(6) 2011. 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 immediate and short-term clinical results of the melody transcatheter pulmonary valve implanted in a high-pressure environment. All data were collected from multiple centers involved in the us ide (investigational device exemption) clinical trial of the melody valve. The study population included 29 patients (age and gender demographics not provided), all of whom were implanted with a medtronic melody valve (serial numbers not provided). Among all patients three deaths occurred. The authors stated the causes of death for all three patients were unrelated to the melody valve or implant procedure. Based on the available information medtronic product was not directly associated with the death(s). Among all patients adverse events included: four cases of moderate stenosis, 10% cases of mild regurgitation, and one transient occlusion of the left coronary artery. The transient occlusion of the left coronary artery occurred following implant and dilation of the melody valve due to native aortic valve leaflet entrapment in the left sinus. The patient became hypotensive, and cardiopulmonary resuscitation was initiated. Within five minutes of performing resuscitation the patient recovered when the melody valve moved approximately 1 mm toward the left ventricular apex which restored flow to the left coronary artery. Based on the available information medtronic product may have been associated with the adverse event(s). 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 Key10973063
MDR Text Key220652733
Report Number2025587-2020-03717
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
Type of Report Initial
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
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 Received11/18/2020
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: 12/08/2020 Patient Sequence Number: 1
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