MAUDE Adverse Event Report: ENDOLOGIX, INC. ENDOLOGIX; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	BEA22-40/I13-40
Health Effect - Clinical Code	Death (1802)
Date of Event	09/15/2020
Type of Reportable Event	Death
Event or Problem Description
Patient undergoing endovascular aaa repair.Endograft was twisted upon deployment.Case was converted to open aaa repair.Fda safety report id# (b)(4).

• Brand Name: ENDOLOGIX
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): ENDOLOGIX, INC.
• MDR Report Key: 10586007
• Report Number: MW5096848
• Device Sequence Number: 372633
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: 00818009015075
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2023
• Device Model Number: BEA22-40/I13-40
• Device Catalogue Number: BEA22-40/I13-40
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 56 YR
• Patient Weight: 86