SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX 9600TFX23A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX 9600TFX23A manufactured by Edwards Lifesciences Llc.

Event Text Entries

[144237576] During a transcatheter pulmonary valve replacement, the balloon of edwards sapien 3 device failed on deployment leaving the valve partially deployed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086375
MDR Report Key8582318
Date Received2019-05-03
Date of Report2019-05-01
Date of Event2019-04-16
Date Added to Maude2019-05-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSAPIEN 3 TRANSCATHETER HEART VALVE
Generic NamePROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
Product CodeNPU
Date Received2019-05-03
Returned To Mfg2019-04-16
Model Number9600TFX
Catalog Number9600TFX23A
Lot Number(17)200730
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES LLC


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-05-03

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