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

Model Number	TV-IL1422160-J
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	01/06/2020
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 an afx2 bifurcated stent graft and afx suprarenal extension, and four (4) ovation ix iliac limb; off-label case due to use of afx with ovation devices.Approximately three (3) years post initial procedure, the patient presented at routine follow-up with an expanded right common iliac aneurysm (rcia).The physician elected to treat the patient by coiling and extending with an additional ovation ix iliac limb.The patient is reportedly doing well.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported expanding right common iliac artery was unconfirmed.The secondary endovascular procedure was confirmed.Additionally, clinical assessment determined that there was evidence to reasonable suggest type 1b endoleak from right iliac artery occurred that were not included in the event as reported.Device, user, procedure or anatomy relatedness of this event could not be determined due to lack of relevant medical images; however, it should be noted that the initial procedure was an off-label case due to use of afx with ovation devices and could have contributed to this event.The final patient status was reported being stable.The device remains implanted; therefore, a device evaluation cannot be completed.The manufacturing lot evaluation confirmed all devices met specifications prior to release.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 an afx2 bifurcated stent graft and afx suprarenal extension, and four (4) ovation ix iliac limb; off-label case due to use of afx with ovation devices.Approximately three (3) years post initial procedure, the patient presented at routine follow-up with an expanded right common iliac aneurysm (rcia).The physician elected to treat the patient by coiling and extending with an additional ovation ix iliac limb.The patient is reportedly doing well.As of date, there have been no additional patient sequelae reported.Subsequent to the initial report, clinical assessment determined that there was evidence to reasonable suggest type 1b endoleak from right iliac artery occurred that were not included in the event as reported.

• 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: 9673117
• Report Number: 3008011247-2020-00014
• Device Sequence Number: 18932736
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422160J1
• UDI-Public: +M701TVIL1422160J1/$$3190121FS01151659P
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 01/21/2019
• Device Model Number: TV-IL1422160-J
• Device Catalogue Number: TV-IL1422160-J
• Device Lot Number: FS011516-59
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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: AFX VELA SUPRARENAL 1621738-025; AFX2 BIFURCATED STENT GRAFT 1607544-002; OVATION IX ILIAC LIMB FS041715-42; OVATION IX ILIAC LIMB FS071816-39; OVATION IX ILIAC LIMB FS082516-23
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR