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

Model Number 9750CM26

Device Problems Difficult to Remove (1528); Material Rupture (1546); Physical Resistance/Sticking (4012)

Patient Problems Extravasation (1842); Hematoma (1884); Low Blood Pressure/ Hypotension (1914)

Event Date 02/01/2023

Event Type  Injury  

Event Description

On [redacted date], during a transcatheter aortic valve replacement (tavr) surgical procedure via transfemoral approach, the balloon on the edwards lifescience delivery device ruptured during aortic valve deployment.This balloon rupture caused the balloon fragment to become stuck outside the delivery system which, in turn, did not allow the delivery system and sheath to be removed.Vascular surgery was called to the operating room (or) as the delivery device for the tavr got stuck at the aortic bifurcation post-deployment due to a perforated balloon.The vascular surgeon was able to pull the device down to the left external iliac artery (eia), but the device could not be removed via the arteriotomy.A left femoral cutdown was performed with extension proximally to the proximal eia allowed removal of tavr delivery device.An endarterectomy and primary repair of the left external iliac artery to common femoral artery was performed (eia-cfa).The vascular surgeon placed viabahn stents in the l eia/proximal common iliac artery (cia).Prior to leaving the or, the wound started displaying signs of an expanding hematoma of the right lower quadrant (rlq) with hypotension.The vascular surgeon performed left brachial cutdown and angiogram which demonstrated extravasation in the right external iliac artery to common femoral artery eia/cfa.A viabahn stent was placed in right eia.Cfa with resolution of the extravasation.Manufacturer response for ultra valve with commander delivery system, sapien 3 ultra system (per site reporter) local manufacturer rep made aware of issue and medsun reporting.Have requested to manufacturer to not supply this specific lot# and we have pulled all inventory with this lot# from use.

• 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: 16333882
• MDR Text Key: 309141112
• Report Number: 16333882
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• 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: 64716965
• 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: 02/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention; Life Threatening
• Patient Age: 28105 DA
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Race: White