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

Model Number	TV-IL1414120-J
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263); Claudication (2550)
Date of Event	11/25/2017
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 iliac limb stent graft system was implanted to treat an abdominal aortic aneurysm.On the final angio of the index procedure, bilateral narrowing of the iliac limbs was observed due to the legs crossing over each other.The physician elected to conclude the case and monitor the patient.Approximately one month post index procedure, the patient returned with claudication.The physician re-intervened by placing two icast stents extending from the iliac limbs to just under the secondary sealing ring.Two balloons were also placed in the space between the secondary sealing rings and the bifurcation to flare the proximal portion of the icast stents.The final angio showed improved flow and the patient is reported as doing well.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 anatomy related, due to the graft position in the angulated (73 degrees) infrarenal aorta.Additionally, a slight twist in the trunk relative to the aortic body legs/iliac limbs likely contributed to the event.The final patient disposition was reported as doing well with no additional patient sequelae reported.Codes: (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: 7117255
• Report Number: 3008011247-2017-00108
• Device Sequence Number: 19199798
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414120J1
• UDI-Public: +M701TVIL1414120J1/$$3201004FS09081705H
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2017

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: 10/04/2020
• Device Model Number: TV-IL1414120-J
• Device Catalogue Number: TV-IL1414120-J
• Device Lot Number: FS090817-05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2017
• Supplement Date Received by Manufacturer: 11/25/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 04/20/2018
• 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: ILIAC LIMB, TV-IL1412120-J LOT#: FS080116-05
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR