MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; TRANSCATHETER HEART VALVE

Model Number	9600LDS26
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Femoral tavr case.Pt needed second valve placed, so second valve and delivery system were opened.Upon removal of femoral delivery system balloon ruptured and femoral sheath torn.Unable to safely remove sheath without performing femoral cut down.Femoral cut down performed and sheath removed.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Common Device Name: TRANSCATHETER HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; irvine CA 92614
• MDR Report Key: 7428563
• Report Number: MW5076480
• Device Sequence Number: 193783
• Product Code: NPT
• UDI-Device Identifier: 00690103193954
• UDI-Public: 00690103193954
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2020
• Device Model Number: 9600LDS26
• Device Catalogue Number: 9600LDS26A
• Device Lot Number: 61204287
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR