MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN 3 ULTRA SYSTEM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Catalog Number 147739

Device Problems Entrapment of Device (1212); Malposition of Device (2616); Activation Failure (3270)

Patient Problem Valvular Insufficiency/ Regurgitation (4449)

Event Date 01/06/2021

Event Type  Injury  

Event Description

Patient presented for an elective transfemoral aortic valve replacement (tavr).Past medical history includes severe aortic stenosis and right common and external iliac artery stenting.Access was initiated in the right femoral artery under ultrasound and angiography.The valve was positioned and deployed, however the ventricular side of the valve did not dilate appropriately.The partially deployed valve was pulled distally beyond the aortic valve and into the aorta.It was then determined the right iliac stent was found on the ventricular end of the tavr valve, restricting from deployment.The tavr and iliac stent were pulled back beyond the arch vessels in the transverse to descending aorta as the valve balloon would not come off of the stent.A successful attempt followed in dislodging the tavr balloon from the valve.Attempts to then fracture the stent were unsuccessful.Attempts to snare and separate the stent from the valve were not successful.The procedure was then concluded.Surgical intervention for removal of the valve and stent is required.A second tavr procedure was performed successfully 5 days later.Further intervention for retained valve/stent is under evaluation.

• Brand Name: SAPIEN 3 ULTRA SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 11243159
• MDR Text Key: 229118438
• Report Number: 11243159
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 147739
• Device Lot Number: 7566839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30660 DA