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

Model Number	TV-IL1416160-J
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
The patient was initially treated with an ovation ix iliac limb and afx2 system, which is currently outside the indications for use.The patient underwent a previous re-intervention for a reported type ib endoleak (reference 3008011247-2019-00067) where an additional ovation ix limb was implanted.Approximately 2-months post re-intervention for the type ib endoleak the patient presented for a routine follow-up and a computed tomography was completed revealing a suspected kink in the device and narrowing with diminished flow.The physician treated the patient with a non-endoglogix wall stent successfully resolving the kink.The patient is reported as stable and will continue to be monitored.
Additional Manufacturer Narrative
Clinical assessment of the reported event was unable to be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made; however, denied due to patient authorization requirements.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.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.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 8777931
• Report Number: 3008011247-2019-00108
• Device Sequence Number: 2638798
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416160J1
• UDI-Public: +M701TVIL1416160J1/$$3210508FS05031851P
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2021
• Device Model Number: TV-IL1416160-J
• Device Catalogue Number: TV-IL1416160-J
• Device Lot Number: FS050318-51
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/09/2020
• 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: AFX LIMB STENT GRAFT.; AFX LIMB STENT GRAFT.; AFX VELA SUPRARENAL.; AFX2 BIFURCATED STENT GRAFT.; OVATION IX ILIAC LIMB.; AFX LIMB STENT GRAFT; AFX LIMB STENT GRAFT; AFX VELA SUPRARENAL; AFX2 BIFURCATED STENT GRAFT; OVATION IX ILIAC LIMB
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 70 YR