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

Model Number	TV-IL1410100-J
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Thrombosis (2100)
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.
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 year and eight months post initial procedure, the patient presented emergently with leg pain and limb thrombosis.The physician elected to treat the patient by performing bilateral endarterectomies, and implanting bilateral self-expanding stents in the common and external iliacs.The physician also implanted a 10mm atrium (non-endologix) stent in the sealing rings in response to an abnormally small aortic flow lumen (approximately 9mm).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.The left iliac limb occlusion and thrombosis complaint is confirmed.The left iliac limb occlusion was most likely due to the pre existing stenosis in the external iliac artery.The event is most likely anatomy related.The proximal stenosis in the sealing ring of 9mm is confirmed.The causation for the proximal stenosis is indeterminate.Device, user, procedure or anatomy relatedness of this complaint could not be determined.There were no procedure related harms identified.The final patient status was discharged on the third post operative day home stable following a secondary endovascular procedure with non endologix products.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: 9845388
• Report Number: 3008011247-2020-00041
• Device Sequence Number: 726707
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1410100J1
• UDI-Public: +M701TVIL1410100J1/$$3200505FS102616327
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 05/05/2020
• Device Model Number: TV-IL1410100-J
• Device Catalogue Number: TV-IL1410100-J
• Device Lot Number: FS102616-32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 08/11/2020
• 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 FS093015-51.; OVATION IX MAIN BODY FS041118-60.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR