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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Valve Stenosis (2024); Regurgitation, Valvular (2335); Pulmonary Valve Insufficiency/ Regurgitation (4452); Respiratory Insufficiency (4462)
Event Date 11/02/2020
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 approximately seven years, six months and 11 days following the implant of this transcatheter bioprosthetic pulmonary valve, an angiogram revealed the moderate to severe pulmonary insufficiency and mild stenosis. A gradient of 29 mmhg was reported with a valve diameter of 18 millimeter (mm). The valve and the pre-stents were dilated using a 22mm non-medtronic high pressure balloon. Additional cp covered stents were implanted. A second transcatheter bioprosthetic pulmonary valve melody valve was implanted. All stents and the melody valve were dilated up to 22 mm using a 22 mm non-medtronic balloon. The final result following the implant of the second melody was a gradient of 11 mmhg. 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, MN 
EI  
7635055378
MDR Report Key10792267
MDR Text Key214779505
Report Number2025587-2020-03443
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,Followup
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/24/2014
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 Received12/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/13/2012
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: 11/05/2020 Patient Sequence Number: 1
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