MELODY TRANSCATHETER PULMONARY VALVE PB 10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-30 for MELODY TRANSCATHETER PULMONARY VALVE PB 10 manufactured by Medtronic Heart Valves Division.

Event Text Entries

[185600115] Citation: virk sa et al. Percutaneous pulmonary valve implantation: a systematic review of clinical outcomes. Int j cardiol. 2015 dec 15;201:487-9. Doi: 10. 1016/j. Ijcard. 2015. 08. 119. Epub 2015 aug 18. Earliest date of publish used for event date and death date. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without the return of the product, no definitive conclusion can be made regarding the clinical observations. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185600116] Medtronic received information via literature regarding an assessment of the clinical outcomes in patients with right ventricular outflow tract (rvot) dysfunction who underwent percutaneous pulmonary valve implantation (ppvi). All data were collected from a meta-analysis systematic review of twelve studies between 2008 and 2014. The study population included 677 patients and was predominantly male with a mean age of 21 years. Of those, 602 were implanted with medtronic melody transcatheter pulmonary valves. No serial numbers were provided. Among all patients, 5 deaths were reported. Of those, an unidentified number may have been due to endocarditis (earliest case occurred at 1. 9 months after ppvi). Based on the available information, medtronic product may have been associated with the deaths. Among all patients, adverse events included: conversion to surgery; conduit rupture; endocarditis (earliest case occurred at 1. 9 months after ppvi); valve explant due to endocarditis; valve embolization; pulmonary artery obstruction; coronary artery compression; and restenosis and rvot reintervention due to stent fractures. Based on the available information, medtronic product was associated with the adverse events. Among all patients, malfunctions included: stent fractures that did not require intervention. Based on the available information, medtronic product was associated with the malfunctions. No additional adverse patient effects or product performance issues were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2025587-2020-01009
MDR Report Key9900323
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2015-08-18
Date Mfgr Received2020-03-25
Date Added to Maude2020-03-30
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 TRANSCATHETER PULMONARY VALVE
Generic NamePULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
Product CodeNPV
Date Received2020-03-30
Model NumberPB 10
Catalog NumberPB 10
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. Death 2020-03-30

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