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

Model Number	TV-IL1414100-J
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	10/05/2017
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 a follow up where angiogram revealed a type ia endoleak, a type ii endoleak and an occluded left iliac limb.The physician elected to re-intervene by performing a partial explant.The left collar and suprarenal portion of the ovation main body was left in place.The rest of the main body and the right iliac limb were removed.Physician sewed in a graft below the left renal and attached it to the right common iliac.The occluded left limb was left in place as to not disturb the graft and send debris down the left iliac system.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the inadequate stent graft patency was found to be unknown/undetermined due to the lack of relevant medical information and imaging studies.There were no reports of additional negative patient sequelae.Patent lumbar arteries and inferior mesenteric arteries are a cautionary product use condition and were the cause of the type ii endoleak (non-device issue).A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.(b)(4).

• 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: 6998107
• Report Number: 3008011247-2017-00074
• Device Sequence Number: 16440170
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414100J1
• UDI-Public: +M701TVIL1414100J1/$$3200116FS111116357
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

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: 01/16/2020
• Device Model Number: TV-IL1414100-J
• Device Catalogue Number: TV-IL1414100-J
• Device Lot Number: FS111116-35
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: Required Intervention
• Patient Age: 69 YR