MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM

Model Number	9600LDS26
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Femoral tavr case.Pt needed a second valve placed, so a 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: EDWARDS COMMANDER DELIVERY SYSTEM
• Manufacturer (Section D): EDWARDS LIFESCIENCES; irvine CA 92614
• MDR Report Key: 7457910
• Report Number: 7457910
• Device Sequence Number: 173389
• 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: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/16/2018
• Report Date (Section F): 04/16/2018

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2018
• 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
• Date Report Sent to FDA: 04/16/2018