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

Model Number	TV-IL1428160-J
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Abdominal Pain (1685); Failure of Implant (1924)
Date of Event	08/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient and will not be returned for evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Reportedly this was an off label case.The patient was admitted to the er with abdominal and back pain.Computerized tomography revealed a type 1b endoleak of the patients left iliac limb.At the time of the index procedure, the physician was aware that the limb in this iliac was unlikely provide a long-term seal but had embolized the contralateral hypogastric and didn't want to embolize both hypogastrics.On (b)(6) 2018, two additional ovation ix iliac limbs were implanted.No additional event or patient information is available.
Additional Manufacturer Narrative
Based on the clinical assessment performed the type ib endoleak is confirmed.The most likely root cause is device related.The reported off label case is refuted; although, both iliac arteries were tortuous yet were within specifications.Procedure related harms could not be determined.The final patient disposition was not reported.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.(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: 7907153
• Report Number: 3008011247-2018-00205
• Device Sequence Number: 11159541
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428160J1
• UDI-Public: +M701TVIL1428160J1/$$3210713FS07101838V
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/26/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2021
• Device Model Number: TV-IL1428160-J
• Device Catalogue Number: TV-IL1428160-J
• Device Lot Number: FS071018-38
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/17/2018
• 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 EXTENDER (LN FS040618-23); OVATION IX ILIAC LIMB (LN FS060618-79); OVATION IX ILIAC LIMB (LN FS060718-43); OVATION IX ILIAC LIMB (LN FS121617-64); OVATION IX MAIN BODY (LN FS052318-06); OVATION IX EXTENDER (LN FS040618-23); OVATION IX ILIAC LIMB (LN FS060618-79); OVATION IX ILIAC LIMB (LN FS060718-43); OVATION IX ILIAC LIMB (LN FS121617-64); OVATION IX MAIN BODY (LN FS052318-06)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR