EDWARDS SAPIEN TRANSCATHETER HEART VALVE VALVE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-16 for EDWARDS SAPIEN TRANSCATHETER HEART VALVE VALVE UNKNOWN manufactured by Edwards Lifesciences.

MAUDE Entry Details

Report Number2015691-2019-03824
MDR Report Key9200586
Date Received2019-10-16
Date of Report2019-09-19
Date of Event2014-01-01
Date Mfgr Received2019-11-15
Date Added to Maude2019-10-16
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 ContactMS. FRANCES PRESTON
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492505190
Manufacturer G1EDWARDS LIFESCIENCES LLC
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEDWARDS SAPIEN TRANSCATHETER HEART VALVE
Generic NamePULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
Product CodeNPV
Date Received2019-10-16
Model NumberVALVE UNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES
Manufacturer Address1 EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-16

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