MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC COMMANDER VALVE DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750C26

Device Problems Disconnection (1171); Stretched (1601); Physical Resistance/Sticking (4012)

Patient Problems Perforation (2001); Pseudoaneurysm (2605); Unspecified Tissue Injury (4559)

Event Date 09/06/2022

Event Type  Injury  

Event Description

The valve crossed and the position was confirmed with aortography.Once we were happy with the position, we performed rapid pacing at 180 bpm and aortography was performed and the valve was deployed.The result was in excellent position with no aortic insufficiency by transthoracic echo and aortography.The balloon delivery system was removed and there was more resistance to the removal of the balloon system.On observation, there was a disconnection between the proximal balloon and the shaft with some stretching of the wire braid.There were 4 sharp plastic tines that were exposed at the base of the balloon.The sheath expansion membrane was completely torn.Abdominal aortogram showed pseudo aneurysm at the level of the ima, there was no extravasation.Interventional radiologist consulted intraoperatively for the aortic injury and aortic cuff placement.There was a penetrating ulcer to the aorta treated with a covered stent with a good seal.There will be a follow up cta in one month to ensure continued functioning of the stent.Within normal range throughout hospitalization to assess for delated hemorrhage.Fda safety report id# (b)(4).

• Brand Name: COMMANDER VALVE DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 15455043
• MDR Text Key: 300326228
• Report Number: MW5112124
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750C26
• Device Lot Number: 64415049
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White