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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 Calcified (1077)
Patient Problem Pulmonary Valve Stenosis (2024)
Event Date 04/23/2018
Event Type  Injury  
Manufacturer Narrative
The device remains implanted, therefore no product analysis can be performed. Without return of the device, a conclusive cause cannot be determined. Conclusion: since the valve has been implanted for over 5 years, it¿s very unlikely that the reported calcification is due to any potential manufacturing issue. Calcification is an inherent risk of bioprosthetic valves. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that approximately five years and two months following the implant of this transcatheter pulmonary bioprosthetic valve, a second transcatheter pulmonary bioprosthetic valve was implanted valve-in-valve due to calcification and stenosis. 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 Key7595901
MDR Text Key110874782
Report Number2025587-2018-01458
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 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/12/2014
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 Received04/23/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/02/2012
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: 06/13/2018 Patient Sequence Number: 1
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