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

Model Number	TV-IL1422120-J
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Approximately one (1) month post initial procedure, a right-side type ib endoleak was detected by ct (computed topography) during routine follow-up.The physician elected to treat the patient by embolizing the hypogastric artery and implanting an additional iliac limb ovation ix device on (b)(6) 2019.The endoleak was successfully resolved and the patient is reportedly doing well.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type ib endoleak from the right side and secondary endovascular procedure was confirmed.The event is most likely user related due to the off label iliac anatomy.The procedure related harms for this event could not be determined.The final patient status was reported being stable.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Approximately one (1) month post initial procedure, a right-side type ib endoleak was detected by ct (computed topography) during routine follow-up.The physician elected to treat the patient by embolizing the hypogastric artery and implanting an additional iliac limb ovation ix device on (b)(6) 2019.The endoleak was successfully resolved and the patient is reportedly doing well.As of date, there have been no additional patient sequelae reported.Subsequent to the initial report, clinical assessment determined that the initial implant was an off-label case due to right coronary iliac artery measuring at 50.6mm (ifu states the measurement should be between 8- 25mm) and the sac size was 70.2mm.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 8885913
• Report Number: 3008011247-2019-00129
• Device Sequence Number: 19512188
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422120J1
• UDI-Public: +M701TVIL1422120J1/$$3211022FS10151875F
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

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: 10/22/2021
• Device Model Number: TV-IL1422120-J
• Device Catalogue Number: TV-IL1422120-J
• Device Lot Number: FS101518-75
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 07/22/2020
• 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: FS021519-10.; OVATION IX ILIAC LIMB: FS040119-27.; OVATION IX MAIN BODY: FS011419-10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR