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

Model Number	TV-AB2080-J
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient returned for an unknown reason where a type i endoleak was observed.The physician elected to re-intervene by placing a palmaz stent within the device and ballooning.Another ovation limb was placed as well to extend the seal zone.A small endoleak was still present at the conclusion of the procedure and the physician elected to monitor the patient.The patient is reported to be doing well and as of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the reported persistent type ia endoleak.There was evidence to suggest that the endoleak type ia was a persistent leak at implant that was not included in the event as reported.This was discovered on (b)(6) 2018 during review of the implant angiogram on (b)(6) 2016.The most likely cause of the endoleak type ia is device related.Additionally there was evidence to reasonably support and endoleak type ib.The most likely cause of the type ib leak is anatomy related.Procedure related harms for this complaint could not be determined.The final patient status was reported to be doing well and under surveillance due to a persistent endoleak post repair.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.Correction: (b)(4).

• 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: 7479676
• Report Number: 3008011247-2018-00081
• Device Sequence Number: 1513132
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2080J1
• UDI-Public: +M701TVAB2080J1/$$3181130FS11201505V
• Combination Product (Y/N): N
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 11/30/2018
• Device Model Number: TV-AB2080-J
• Device Catalogue Number: TV-AB2080-J
• Device Lot Number: FS112015-05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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: TV-IL1410100-J; OVATION IX ILIAC LIMB: TV-IL1410120-J
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR