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

Model Number	TV-IL1410120-J
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/01/2019
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 three (3) years post initial procedure, the patient presented with a leak in the limb area (classified as a type ib endoleak) as detected by ct (computed tomography) scan.The physician elected to treat the patient by implanting an ovation ix iliac limb on (b)(6) 2020.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 therefore no evaluation was completed.At the completion of the clinical assessment, the type 1b endoleak from right iliac artery and secondary endovascular procedure events were confirmed.Additionally, a persistent type 1a endoleak and a type 2 endoleak (non -device failure) from the lumbar artery were identified.These events are most likely anatomy related due to heavy calcium around the landing zone extending and hostile neck anatomy.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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, the patient presented with a leak in the limb area (classified as a type ib endoleak) as detected by ct (computed tomography) scan.The physician elected to treat the patient by implanting an ovation ix iliac limb on (b)(6) 2020.As of date, there have been no additional patient sequelae reported.Additional information: note: this patient had a previous reported event under 3008011247-2018-00081 for a type 1a and 2 endoleaks that was treated with palmaz (non- endologix) bare metal stent and an ovation ix extender.During the clinician assessment, a persistent type 1a endoleak and type 2 endoleak (non - device failure) from the lumbar artery were identified.The final patient status was reported to be stable.

• 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: 9654119
• Report Number: 3008011247-2020-00011
• Device Sequence Number: 2361917
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1410120J1
• UDI-Public: +M701TVIL1410120J1/$$3190323FS01191609L
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 03/23/2019
• Device Model Number: TV-IL1410120-J
• Device Catalogue Number: TV-IL1410120-J
• Device Lot Number: FS011916-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 08/14/2020
• 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: NON - ENDOLOGIX - PALMAZ STENT; OVATION IX EXTENDER FS122117-40; OVATION IX FS122117-40; OVATION IX ILIAC LIMB FS070215-14; OVATION IX MAIN BODY FS112015-05; OVATION IX EXTENDER FS122117-40; OVATION IX ILIAC LIMB FS070215-14; OVATION IX MAIN BODY FS112015-05
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR