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

Model Number	TV-IL1422120-J
Medical Device Problem Codes	Leak/Splash (1354); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2018, an ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.On (b)(6) 2018, endologix was made aware of an endoleak.A computerized tomography (ct) was performed on (b)(6) 2018 and a type 1b endoleak was confirmed.On (b)(6) 2018, the physician elected to implant an additional iliac limb to resolve this endoleak.The patient was reported in good condition and there have been no additional patient sequelae reported.
Event or Problem Description
At the completion of the clinical assessment on (b)(6) 2018, clinical was able to find substantial evidence to support the following additional findings of a type 1a endoleak of the main body.A separate report will be filed for this endoleak.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following event of a type 1b endoleak with cephalic movement of the left iliac limb up into the sac and a type 1a endoleak of the main body.A separate report will be filed for this 1a endoleak.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined.The final patient status was reported to be in stable post the secondary endovascular procedure endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• 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: 7741541
• Report Number: 3008011247-2018-00168
• Device Sequence Number: 1040693
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422120J1
• UDI-Public: +M701TVIL1422120J1/$$3210330FS032118418
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/03/2018

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: 03/30/2021
• Device Model Number: TV-IL1422120-J
• Device Catalogue Number: TV-IL1422120-J
• Device Lot Number: FS032118-41
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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, LOT # FS032918-66; MAIN BODY. LOT # FS022218-45
• Outcome Attributed to Adverse Event: Required Intervention