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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

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EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 9600TFX
Event Date 05/30/2018
Event Type  Death  
Manufacturer Narrative

(b)(4). Column a indicates whether an event is a ¿new event or follow-up¿. Columns m and n associate a device with the event type (e. G. It is considered most appropriate to assign an event of ¿major vascular complication¿ to a sheath, rather than the sapien 3 valve). Associated device information is not included in the data received from the registry; the products were assigned by edwards based on standard kitting and the ¿implant approach¿ field available in the registry. [(b)(4)].

 
Event Description

This report summarizes 297 deaths. Thv/tvt registry alternative summary report (asr) adverse event submission for may 2018 data extract for deaths for the sapien 3 valve.

 
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Brand NameEDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
Type of DeviceAORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
frances preston
1 edwards way
irvine , CA 92614
9492505190
MDR Report Key7894959
Report Number2015691-2018-03871
Device Sequence Number1
Product CodeNPT
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2018
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9600TFX
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/20/2018 Patient Sequence Number: 1
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