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

Model Number	TV-IL1414100-J
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/08/2018
Type of Reportable Event	Serious Injury
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 events of a type ib endoleak of the right iliac limb and a type ii (lumbar) endoleak.The most likely cause of the loss of seal was the protruding calcification at the confluence of the right hypo gastric artery in the distal landing zone.Procedure related harms included type ii endoleak from the lumbar arteries and/or inferior mesenteric artery.Patient was discharged home in stable condition on the first post-operative day.To date there has been no reports of further negative patient sequalae.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.
Event or Problem Description
On (b)(6) 2017, the patient was initially implanted with a bifurcated stent, a suprarenal extension and a limb extension.On (b)(4) 2018, endologix was made aware of an indeterminate endoleak with the presence of a type ii.There is no change in aneurysm sac size and no plan to intervene.On the completion of clinical assessment ((b)(6) 2018), the indeterminate endoleak was confirmed to be a type 1b endoleak of the iliac limb for the ovation ix product line.The patient is currently being monitored.No additional patient sequelae has been reported.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7443959
• Report Number: 3008011247-2018-00066
• Device Sequence Number: 1768735
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414100J1
• UDI-Public: +M701TVIL1414100J1/$$3201004FS09081758N
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 03/23/2018

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: 10/04/2020
• Device Model Number: TV-IL1414100-J
• Device Catalogue Number: TV-IL1414100-J
• Device Lot Number: FS090817-58
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/19/2018
• 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: AFX, SUPRARENAL EXTENSION, LOT # 1751547-001; AFX2, BIFURCATED STENT LOT # 1722336-005
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR