MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; ILIAC LIMB

Model Number	TV-IL1414140-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	04/30/2018
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
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The physician reported that at the routine 2 month follow-up, the patient presented with a potential type ib endoleak.A re-intervention was performed where an additional extension was placed to extend the distal seal.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.
Additional Manufacturer Narrative
At the completion of the investigation, the reported type ib endoleak from the left common iliac artery is confirmed.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be in stable condition and on surveillance.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.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: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7553682
• Report Number: 3008011247-2018-00113
• Device Sequence Number: 19340240
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414140J1
• UDI-Public: +M701TVIL1414140J1/$$3210117FS11221731C
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup

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: 01/17/2021
• Device Model Number: TV-IL1414140-J
• Device Catalogue Number: TV-IL1414140-J
• Device Lot Number: FS112217-31
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 10/30/2018
• 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: OVATION IX ILIAC LIMB-LOT: FS102017-28; OVATION IX-MAIN BODY-LOT: FS121117-73
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR