MELODY TRANSCATHER PULMONARY VALVE PB1018

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for MELODY TRANSCATHER PULMONARY VALVE PB1018 manufactured by Medtronic Heart Valves Division.

Event Text Entries

[185976063] Product analysis: the device remains implanted, therefore no product analysis can be performed. Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185976064] Medtronic received information that approximately eight years and ten months after the implant of this transcatheter bioprosthetic pulmonary valve, the valve was replaced valve-in-valve due to severe pulmonary insufficiency and right ventricle dilation. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2025587-2020-01039
MDR Report Key9908800
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2017-05-31
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC HEART VALVES DIVISION
Manufacturer Street1851 E DEERE AVE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal Code92705
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMELODY TRANSCATHER PULMONARY VALVE
Generic NamePULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
Product CodeNPV
Date Received2020-03-31
Model NumberPB1018
Catalog NumberPB1018
Device Expiration Date2009-09-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC HEART VALVES DIVISION
Manufacturer Address1851 E DEERE AVE SANTA ANA CA 92705 US 92705


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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