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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 (THV); AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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EDWARDS LIFESCIENCES LLC EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV); AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 9600TFX
Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 06/09/2021
Event Type  malfunction  
Event Description
When advancing the transcatheter heart valve, from the edwards sapien 3 transcatheter heart valve with the edwards commander delivery system, over the wire into the aortic valve the device would not advance and got stuck on the wire.Physicians tried to manipulate the device but ended up removing the device and wire as one.Representative prepped new device, recrossed transcatheter heart valve with new wire, and new transcatheter heart valve deployed without issue.
 
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Brand Name
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)
Type of Device
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
MDR Report Key12127984
MDR Text Key260268580
Report Number12127984
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number9600TFX
Device Catalogue Number9600TFX29A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/22/2021
Date Report to Manufacturer07/07/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age30660 DA
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