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

Model Number	TV-IL1414100-J
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Occlusion (1984); Thrombosis (2100); Stenosis (2263)
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 two (2) months post initial procedure, the patient presented with a bunched and thrombosed left proximal iliac limb.However, the exact date of event is unknown.The physician plans to re-intervene and will continue to monitor the patient.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 occlusion event is confirmed by medical records only.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The procedure related harm identified was access site complication (left groin hematoma).The final patient status was discharged on the third post operative day home stable following a thrombolysis procedure with addition of a non endologix limb stent.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.Corrections: b5: describe event or problem, h6: result code: remove code 3233, h6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Approximately two (2) months post initial procedure, the patient presented with a bunched and thrombosed left proximal iliac limb.However, the exact date of event is unknown.The physician plans to re-intervene and will continue to monitor the patient.As of date, there have been no additional patient sequelae reported.Additional information: an intervention was completed.The physician elected to implant non- endologix ( luminexx and palmaz ) stents to treat this event.Clinical assessment identified occlusion of the left iliac.

• 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: 9555476
• Report Number: 3008011247-2020-00002
• Device Sequence Number: 1953873
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414100J1
• UDI-Public: +M701TVIL1414100J1/$$3211212FS11091841C
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/09/2019

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: 12/12/2021
• Device Model Number: TV-IL1414100-J
• Device Catalogue Number: TV-IL1414100-J
• Device Lot Number: FS110918-41
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 01/06/2020
• 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 FS011118-40; OVATION IX MAIN BODY FS031119-08
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 66 YR