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

Model Number	TV-IL1416160-J
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
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) year post initial procedure, a type ib endoleak was detected during routine follow-up.However, the exact date of event is unknown.The physician elected to treat the patient by implanting two (2) additional iliac limb ovation ix devices on (b)(6) 2019.The patient is reportedly doing well and the leak was confirmed resolved post re-intervention.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Based on the description of the event and information available, the clinical assessment, the type ib endoleak is refuted rather there is a persistent type ib from the left common iliac artery with a non-endologix device.Furthermore, aneurysm growth (23 to 34mm) was identified and most likely related to the persistent endoleak.The pre-op computed tomography revealed the non-endologix implants were present prior to the patient being treated with ovation which is outside the indications for use and therefore, the root cause of the reported event is most likely user related.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.Corrected data remove device code 3190, add 1494, add 2017.Remove results code 3233, add 4206.Remove conclusion code 11, add 24, 61, 4310.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 8843148
• Report Number: 3008011247-2019-00122
• Device Sequence Number: 16208083
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416160J1
• UDI-Public: +M701TVIL1416160J1/$$3201117FS10031733G
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 11/17/2020
• Device Model Number: TV-IL1416160-J
• Device Catalogue Number: TV-IL1416160-J
• Device Lot Number: FS100317-33
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/30/2019
• 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 EXTENDER: FS031618-26; OVATION IX ILIAC LIMB: FS022217-46; OVATION IX ILIAC LIMB: FS112717-26; OVATION IX MAIN BODY: FS092217-65; OVATION IX EXTENDER: FS031618-26; OVATION IX ILIAC LIMB: FS022217-46; OVATION IX ILIAC LIMB: FS112717-26; OVATION IX MAIN BODY: FS092217-65
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR