MAUDE Adverse Event Report: ENDOLOGIX OVATION IX; MAIN BODY

Model Number	TV-AB2080-J
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The ovation ix devices were implanted to treat an abdominal aortic aneurysm in 2016.At the 30 day follow-up visit, there was a note of a endoleak in the proximal portion of the stent.It was noted from this ct images, some angulation of the neck as expected, mild type 1a endoleak but no sac growth.At the 12 month follow up visit ct on (b)(6) 2017, there is evidence of a type ii endoleak.There appeared to be 3 locations for endoleak being observed: proximal portion of the stent, ima and distal portion.At the 1 year follow up ct, the proximal endoleak still existed.The patient continues to be monitored.No additional patient sequelae has been report.
Additional Manufacturer Narrative
At the completion of the investigation, the reported endoleak type ia and type ii are confirmed.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be under surveillance.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7563296
• Report Number: 3008011247-2018-00118
• Device Sequence Number: 18883127
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2080J1
• UDI-Public: +M701TVAB2080J1/$$3160727FS071415011
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: Physician
• Device Expiration Date: 07/31/2016
• Device Model Number: TV-AB2080-J
• Device Catalogue Number: TV-AB2080-J
• Device Lot Number: FS071415-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 08/03/2018
• 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: Other
• Patient Age: 76 YR