EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE 9750TFX26 9750TFX26A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-20 for EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE 9750TFX26 9750TFX26A manufactured by Edwards Lifesciences Llc.

MAUDE Entry Details

Report Number8716062
MDR Report Key8716062
Date Received2019-06-20
Date of Report2019-04-24
Date of Event2019-04-10
Report Date2019-04-24
Date Reported to FDA2019-04-24
Date Reported to Mfgr2019-06-20
Date Added to Maude2019-06-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
Generic NamePROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
Product CodeNPU
Date Received2019-06-20
Model Number9750TFX26
Catalog Number9750TFX26A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES LLC
Manufacturer AddressONE EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Life Threatening; 3. Other; 4. Required No Informationntervention 2019-06-20

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