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

Model Number	TV-IL1418160-J
Medical Device Problem Codes	Complete Blockage (1094); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
The patient was initially treated with ovation ix to treat an abdominal aortic aneurysm.The patient presented approximately 1-month post-op with left leg claudication.A cta scan revealed a total occlusion of the left iliac limb stent graft.The physician is planning to treat the patient by fem-fem bypass- right common fem to left common fem.The treatment has not yet been scheduled.The current patient condition was not initially reported.
Event or Problem Description
Subsequent to the initial report additional information was received reporting that re-intervention was performed in mid (b)(6) 2018; however, detailed information was not provided.
Additional Manufacturer Narrative
Based on the description of the event and provided medical records, clinical assessment confirmed the reported event of left iliac occlusion.The occlusion is most likely user and/or anatomy related due to the off label neck angle and the smaller left limb diameter at the superior stent margin, and/or placement of a second limb extension distally.Procedure related harms and the final patient disposition could not be determined.It was been reported that the patient had surgical intervention.The final patient status was not reported.In addition, clinical assessment determined that there was evidence to reasonable suggest a type ia endoleak via review of the one month post implant computed tomography scan.The type ia endoleak is most likely user related due to the off label neck angle.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• 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: 8210923
• Report Number: 3008011247-2019-00002
• Device Sequence Number: 13867272
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418160J1
• UDI-Public: +M701TVIL1418160J1/$$3210723FS07171850W
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2021
• Device Model Number: TV-IL1418160-J
• Device Catalogue Number: TV-IL1418160-J
• Device Lot Number: FS071718-50
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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 (LN FS040518-61).; OVATION IX ILIAC LIMB (LN FS060718-44).; OVATION IX MAIN BODY (LN FS061218-29).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR