MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; MAIN BODY

Model Number	TV-AB2080-J
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Seven (7) days post initial procedure, a type 1a endoleak and 3a endoleak were identified.An intervention was completed.The physician elected to use non -endologix stents and ballooning to resolve these reported events.As of the date of this report, 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 type ia endoleak (persistent after repair procedure done (b)(6) 2020) event is confirmed.The event is most likely user and anatomy related due to the off label proximal juxtarenal angulation (105 degrees) should be equal to or less than 60 degrees.The reported type iiia endoleak is unconfirmed and is confirmed as an indeterminate endoleak and device, user, procedure or anatomy relatedness of this event could not be determined for this endoleak.No procedure related harms were identified.The final patient status was discharged on the third post operative day home stable.The clinical assessment determined that there was evidence to reasonably suggest a type ii endoleak of the lumber occurred.The type ii endoleak is anatomy related and is not related to the device.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 event and similar events in the event further investigation is needed.Corrections: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem.H6: device code: remove code 3190.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Seven (7) days post initial procedure, a type 1a endoleak and 3a endoleak were identified.An intervention was completed.The physician elected to use non-endologix stents and ballooning to resolve these reported events.As of the date of this report, there have been no additional patient sequelae reported.Additional information: the clinical assessment determined that there was evidence to reasonably suggest a type ii endoleak (non- device related) of the lumbar occurred.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10222335
• Report Number: 3008011247-2020-00075
• Device Sequence Number: 16750556
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2080J1
• UDI-Public: +M701TVAB2080J1/$$3210921FS091018070
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 09/21/2021
• Device Model Number: TV-AB2080-J
• Device Catalogue Number: TV-AB2080-J
• Device Lot Number: FS091018-07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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, LOT FS032819-02; ILIAC LIMB, LOT FS031119-49; POLYMER, LOT FF010720-03
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR