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

Model Number	TV-IL1418140-J
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Stenosis (2263)
Date of Event	02/01/2018
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 iliac limb stent graft system was implanted to treat an abdominal aortic aneurysm.During placement of the ipsilateral limb, the physician mistakenly placed the limb above the celiac artery and sma.Another 18 mm limb was placed up the ipsilateral limb to extend it to the level of the 2nd sealing ring of the main body.The contralateral limb was placed without issue and the final angio revealed adequate seal of the aneurysm.The patient is reported to be in excellent condition, however, the physician is concerned about the long term durability of the aortic flow due to the ispi limb being extended into the suprarenal aorta.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 malposition of the ipsilateral limb was found to be user related due to the unintentional user error of deploying the limb into the suprarenal aorta.The most likely cause of the inadequate stent graft patency of the left common iliac artery stent could not be determined due to a lack of imaging.There were no procedure related harms identified.The patient was discharged home on the first post-operative day in stable condition.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: 7304147
• Report Number: 3008011247-2018-00028
• Device Sequence Number: 11324864
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418140J1
• UDI-Public: +M701TVIL1418140J1/$$3201117FS11021766M
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 02/01/2018

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: 11/17/2020
• Device Model Number: TV-IL1418140-J
• Device Catalogue Number: TV-IL1418140-J
• Device Lot Number: FS120817-09
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 05/08/2018
• 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-IL1416140-J; OVATION IX ILIAC LIMB:TV-IL1416140-J; OVATION IX ILIAC LIMB:TV-IL1418160-J; OVATION IX MAIN BODY:TV-AB2980-J
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR