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

Model Number 9600LDS29

Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)

Patient Problems Cardiopulmonary Arrest (1765); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 07/22/2020

Event Type  Injury  

Event Description

As the device was being deployed, the physician noted that blood was coming back into the indeflator of the valve delivery system.The indeflator was disconnected, and there was noted to be risk, pulsatile bleed back from the delivery system signifying that the tear in the balloon was large.Upon removing the valve and esheath, there was resistance in the iliac artery and the patients blood pressure dropped, cpr was initiated.With removal of the undeployed valve, it was noted that the external iliac artery had avulsed and come out with the valve as it was stuck on the valve.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10395252
• MDR Text Key: 202523994
• Report Number: 10395252
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29
• Device Catalogue Number: 9600LDS29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2020
• Date Report to Manufacturer: 08/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 29200 DA