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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 PB1018
Device Problem Gradient Increase (1270)
Patient Problems Pulmonary Valve Stenosis (2024); Low Cardiac Output (2501); Pulmonary Valve Insufficiency/ Regurgitation (4452)
Event Date 12/14/2020
Event Type  Injury  
Manufacturer Narrative
Product analysis: no product was returned. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that four years and ten months following the implant of this transcatheter bioprosthetic pulmonary valve, echocardiogram revealed a gradient of 102 mmhg between the right ventricle (rv) and pulmonary artery, and moderate central pulmonary insufficiency. A magnetic resonance imaging (mri) taken five years after the valve implant revealed a right ventricular end-diastolic volume index of 108, a right ventricular end-systolic volume index of 78 and a right ventricle ejection fracture of 33%. There was no concern of infection or endocarditis. The patient was hospitalized for catheterization and an implant of a second pulmonary valve. Approximately five years, eight months, and 14 days following the valve implant, an angiography taken during the intervention confirmed moderate central pulmonary insufficiency and stenosis of the valve. No stent fractures were visible on the valve nor on the pre-stents. The valve stent showed a waist of 19. 4 mm. Significant stenosis of the right pulmonary artery (rpa) stent and significant stenosis of the right ventricular outflow tract (rvot) distal to the valve/pre stent were also seen on angiography. Angiography showed a minimum rvot diameter of 14 mm. The rpa stenosis was treated with the placement of a new stent and dilation up to 18 mm. After stenting, the pressures were measured. The rpa pressure was reported to be 34 mmhg, the valve pressure was 75 mmhg, and the rv pressure was 112 mmhg. A 22mm covered stent was implanted and then post-dilated to address the supra-valve stenosis. A second tran scatheter bioprosthetic pulmonary valve was then implanted. A post-implant angiography revealed the valve insufficiency has resolved. Echocardiogram revealed the gradient had decreased; a max gradient of 19 mmhg and an estimated rv pressure of 37 mmhg were reported. Outgrowth was not a factor in the valve replacement. 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11118176
MDR Text Key225131313
Report Number2025587-2021-00029
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,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/11/2016
Device Model NumberPB1018
Device Catalogue NumberPB1018
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 Received01/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/08/2014
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: 01/05/2021 Patient Sequence Number: 1
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