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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES LLC EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 9600TFX
Event Date 08/20/2018
Event Type  Injury  
Manufacturer Narrative

Exemption number (b)(4).   this report summarizes 1873 serious injury events.   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.   any line items highlighted in yellow indicate a discrepancy in the registry data; example:  "event date" prior to "implant date".

 
Event Description

Thv/tvt registry alternative summary report (asr) adverse event submission for (b)(6) 2018 data extract for serious injuries 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 LLC
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 Key8172123
Report Number2015691-2018-05353
Device Sequence Number1
Product CodeNPT
Report Source Manufacturer
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Report Date 12/17/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9600TFX
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 Received12/17/2018
Was Device Evaluated By Manufacturer? No
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: 12/17/2018 Patient Sequence Number: 1
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