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

Model Number 9750CM23

Device Problems Difficult to Remove (1528); Material Rupture (1546); Activation Problem (4042)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

During a tavr, (transaortic valve replacement) was being deployed into the aortic valve, at optimal inflation, the balloon rupture occurred during deployment of the valve.The valve was deployed successfully.Since the balloon was ruptured, there was difficulty removing the delivery system through the sheath.The sheath and the edwards delivery system had to be removed simultaneously.There were minor complications at the insertion site which were resolved with percutaneous transluminal angiogram (pta) of the right common femoral artery.The patient was subsequently transferred to the pacu (post anesthesia care unit) in stable condition.Manufacturer response for edward lifescience sapien 3 delivery system, sapien 3 delivery system (per site reporter).Manufacturer rep is always present during this procedure.Was present when balloon ruptured.

• Brand Name: SAPIEN 3 ULTRA SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16350706
• MDR Text Key: 309265451
• Report Number: 16350706
• Device Sequence Number: 1
• Product Code: NPU
• 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: 02/06/2023,02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM23
• Device Catalogue Number: 9750CM23A
• Device Lot Number: 64631859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33945 DA
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White