ENVEO PRO DELIVERY SYSTEM ENVPRO-16

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 ENVEO PRO DELIVERY SYSTEM ENVPRO-16 manufactured by Medtronic Heart Valves Division.

MAUDE Entry Details

Report Number2025587-2020-01038
MDR Report Key9908744
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-11-08
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 NameENVEO PRO DELIVERY SYSTEM
Generic NameAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Product CodeNPT
Date Received2020-03-31
Model NumberENVPRO-16
Catalog NumberENVPRO-16
Lot Number0010007363
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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