EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX29A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX29A manufactured by Edwards Lifesciences.

Event Text Entries

[188405091] Udi reference number: (b)(4). Investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10


[188405092] As reported through the implant patient registry department, three years and eight months post implant of a 29mm sapien 3 valve in the aortic position, the valve was explanted and replaced with a 29mm surgical valve.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2015691-2020-11250
MDR Report Key9908484
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-11
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Device Manufacturer Date2016-03-16
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 ContactMRS. RENEE DORNE
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492506385
Manufacturer G1EDWARDS LIFESCIENCES LLC
Manufacturer StreetONE 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 3 TRANSCATHETER HEART VALVE
Generic NameAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Product CodeNPT
Date Received2020-03-31
Model Number9600TFX29A
Device Expiration Date2017-03-06
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES
Manufacturer AddressONE EDWARDS WAY IRVINE CA 92614 US 92614


Patients

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

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