MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number	TV-IL1418140-J
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Devices remain implanted in patient.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Approximately one (1) month post initial procedure (exact date was not provided), the patient presented with a type ib endoleak due to migration of the left limb.The physician elected to treat the patient by implanting an additional ovation ix iliac limb on (b)(6) 2019.Re-intervention was successful and the endoleak was confirmed resolved.As of date, there have been no additional patient sequelae reported.
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.Clinical assesment shows the left side type ib endoleak due to the cephalic left limb migration into the aorta and secondary endovascular procedure events are confirmed.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The contributing factors for the type 1b endoleak was the cephalic limb migration.The contributing factors for the limb migration could not be determined due to a lack of the pre ct (computed tomography) and/or any relevant medical information.The final patient status was reported being stable.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 SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9613326
• Report Number: 3008011247-2020-00009
• Device Sequence Number: 14120568
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418140J1
• UDI-Public: +M701TVIL1418140J1/$$3220524FS11151806O
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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: 05/24/2022
• Device Model Number: TV-IL1418140-J
• Device Catalogue Number: TV-IL1418140-J
• Device Lot Number: FS111518-06
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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: OVATION IX ILIAC LIMB FS100219-30.; OVATION IX MAIN BODY FS091019-05.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR