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

Model Number 9750CM26

Device Problems Material Rupture (1546); Mechanical Jam (2983); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2022

Event Type  Injury  

Event Description

Cardiologist's explanation.Under ultrasonic guidance, with the use of micropuncture needle, an access was made in right common femoral artery, and a 6 french sheath was inserted.Over the wire 2 perclose sutures were placed and with the help of amplatzer extra stiff wire, a 14 french e-sheath+ was inserted.The valve was advanced through the 14 french sheath and positioned at the aortic annulus under fluoroscopic guidance.The valve was positioned and replaced using standard technique.During valve deployment, there was rupture of the balloon which was immediately identified.The balloon was attempted to be retrieved into the sheath but there was flaring of the esheath+.Therefore we removed the sheath and the ruptured balloon en mass.We exchanged for a stiffer lunderquist wire and continued slowly removing the sheath and it got stuck at the femoral access site.Thereafter a cutdown was performed.Cardiac surgeon's explanation.Ultrasound guided percutaneous access was obtained on the right common femoral artery.The right common femoral artery was "preclosed" with 2 per close devices, and using standard techniques, a 14 french hemostatic sheath was secured in place.Anticoagulation was initiated with heparin.The aortic valve was crossed and with a series of exchanges a safari wire was advanced to the lv apex.After confirmation of correct orientation of the 26 mm s3 ultra valve on the delivery catheter, the valve was crimped and loaded onto the delivery catheter which was then advanced over the exchange wire into the descending aorta.Proper alignment with the valve and balloon on the delivery catheter was achieved. the valve was advanced across the aortic valve. with rapid pacing and under fluoroscopic guidance, the valve was positioned precisely across the aortic valve, and the valve was deployed.Unfortunately the balloon ruptured just at full deployment.Rapid pacing was ceased, and the balloon and delivery system were retracted into the descending aorta without issue.At this point, the delivery system was able to be retracted to the distal external iliac without issue; however, it was not able to be pulled out of the artery.A cutdown on the right femoral artery was done to retrieve it.Days after surgery, an echo showed normal ejection fraction, and a well-functioning valve.

• Brand Name: SAPIEN 3 ULTRA SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 14619091
• MDR Text Key: 293452732
• Report Number: 14619091
• 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: 05/31/2022,05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 64009600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 31755 DA
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White