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

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.

• 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 Key: 11929539
• MDR Text Key: 254032939
• Report Number: 11929539
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: 8042011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Weight: 116