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

Model Number	TV-IL1428160-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/12/2019
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 the ovation ix abdominal stent graft system.Approximately one (1) month post-op, the patient presented for a routine follow-up and a type ib endoleaks was detected.The physician is planning to treat the patient.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type ib endoleak and secondary endovascular procedure was unconfirmed due to lack of the relevant medical information.Device, user, procedure or anatomy relatedness of this event could not be determined.The final patient status was not reported.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: 9187715
• Report Number: 3008011247-2019-00153
• Device Sequence Number: 11270335
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428160J1
• UDI-Public: +M701TVIL1428160J1/$$3220304FS01281919V
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2019

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: 03/04/2022
• Device Model Number: TV-IL1428160-J
• Device Catalogue Number: TV-IL1428160-J
• Device Lot Number: FS012819-19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2019
• Supplement Date Received by Manufacturer: 09/15/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 07/20/2020
• 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: ILIAC LIMB (2).; OVATION CUSTOM SEAL FILL POLYMER.; OVATION IX AORTIC MAIN BODY.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR