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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

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MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHER 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 Insufficiency (2022); Pulmonary Valve Stenosis (2024)
Event Date 11/01/2017
Event Type  Injury  
Manufacturer Narrative
This date is approximate. Product analysis: the product was not returned as it was discarded; therefore, no product analysis can be performed. Conclusion: without return of the product, no definitive conclusions or root cause could be drawn regarding the clinical observations. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that approximately one year eight months and sixteen days following the implant of this transcatheter bioprosthetic pulmonary valve into an existing non-medtronic homograft, the valve was removed and replaced due to stenosis and moderate to severe pulmonary insufficiency. It was also reported that the patient had grown significantly in that time frame which also contributed to the replacement. The valve was surgically replaced with a non-medtronic homograft. No additional adverse patient effects were reported.  .
 
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Brand NameMELODY TRANSCATHER 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 Key9195293
MDR Text Key166145942
Report Number2025587-2019-03152
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/14/2016
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 Received09/24/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/31/2014
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: 10/15/2019 Patient Sequence Number: 1
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