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

Model Number 9750CM26

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 08/19/2022

Event Type  Death  

Event Description

Patient was prepped a 26 mm sapien iii valve and prepped it and checked it for its accuracy and placed it through the edwards sheath.Towards the distal end of the edwards sheath as we were advancing the valve with usual amount of forces, we had a sudden give away of the valve.That was unusual and at this point, the patient's blood pressure dropped.Quick angiography revealed it in the infrarenal area of the right common femoral artery sheath.Quickly placed coda balloon and tried to tamponade it.At this moment acls protocol for hypotension started.The patient also had a prolonged resuscitation and had a rhythm disturbance, including ventricular fibrillation.At this point, a vascular surgeon was called for additional assistance.At this time, deployed introduction of the catheters and wires, etc.After a long trial, we tried to stop this bleeding.We were able to deploy the valve in the distal abdominal aorta using some degree of difficulties to go through we were able to deploy the valve with some degree of difficulty.Diagnosis for use: symptomatic aortic stenosis, cad< status post cabg, pci.Fda safety report id# (b)(4).

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC.
• MDR Report Key: 15282632
• MDR Text Key: 298594803
• Report Number: MW5111660
• Device Sequence Number: 1
• Product Code: NPU
• 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: 08/19/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750CM26
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 64367931
• 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): Death
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White