MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; MAIN BODY

Model Number	TV-AB2380-J
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following event of a type 1a endoleak of the main body.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined.The final patient status was reported to be in stable post the secondary endovascular procedure endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.
Event or Problem Description
At the completion of the clinical assessment on 09/05/2018 for a pervious report event (3008011247-2018-00168), clinical was able to find substantial evidence to support the following additional findings of a type 1a endoleak of the main body.This report is for the type 1a endoleak of the main body only.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7939064
• Report Number: 3008011247-2018-00214
• Device Sequence Number: 1797743
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422120J1
• UDI-Public: +M701TVIL1422120J1/$$3210330FS032118418
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2021
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-IL1422120-J
• Device Lot Number: FS022218-45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ILIAC LIMB, LOT # FS032118-41; ILIAC LIMB, LOT # FS032918-66
• Outcome Attributed to Adverse Event: Required Intervention