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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SAPIEN3; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

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EDWARDS LIFESCIENCES LLC SAPIEN3; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 8042011
Device Problems Difficult to Remove (1528); Failure to Align (2522); Failure to Advance (2524)
Patient Problem Hematoma (1884)
Event Date 05/18/2021
Event Type  malfunction  
Event Description
Tavr (transcatheter aortic valve replacement) procedure.The sapien3ultra delivery system malfunctioned so we could not align the balloon to the valve.Attempted to retrieve the system and replace but it was not possible to remove through the iliac as stent was partly flared by the balloon.Hematoma in r cfa (common femoral artery) area occurred at this point.We readvanced the system, manually aligned as much as possible and were able to deploy with a prolonged pacing run and dual inflation.
 
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Brand Name
SAPIEN3
Type of Device
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
MDR Report Key11929539
MDR Text Key254032939
Report Number11929539
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 05/26/2021
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 Health Professional
Device Model Number8042011
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2021
Event Location Hospital
Date Report to Manufacturer06/03/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age30660 DA
Patient Weight116
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