MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS LIFESCIENCES; EDWARDS COMMANDER DELIVERY SYSTEM

Model Number 9750CM26A

Device Problem Material Rupture (1546)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 05/26/2022

Event Type  Death  

Event Description

Patient prepped and procedure completed in the typical fashion, including pre-op imaging.The sapien valve was mounted on the balloon in the aorta and was advanced to the patient's aortic valve.Positioning of the valve was confirmed with aortography, rapid pacing completed to 180 bpm and valve was deployed.During the valve deployment, the staff in the room heard a "pop" sound and the provider felt unusual movement on the catheter system in his hand.The provider believes it is at this moment that the delivery balloon ruptured.The surgeon believes the balloon rupture was related to contact with a calcification at the sino-tubular junction.Full valve deployment was confirmed by echo with no concerns of valve placement.Initially, the device was left indwelling but the patient quickly became hypotensive.The surgeon attempted to retrieve delivery balloon into sheath but this was unable to be accomplished.Subsequently, the sheath and balloon were removed as a unit.Patient then lost pulses.Cpr, intubation and massive transfusion protocol initiated.Surgeon identified damage to the external and common iliac arteries which were stented successfully during the code.Return of spontaneous circulation was never achieved and patient was pronounced dead after 35 minutes of cpr.

• Brand Name: EDWARDS LIFESCIENCES
• Type of Device: EDWARDS COMMANDER DELIVERY SYSTEM
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 14713071
• MDR Text Key: 294232594
• Report Number: 14713071
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Device Lot Number: 64248606
• 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: 06/06/2022
• Distributor Facility Aware Date: 05/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White