MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR) OVATION IX; ILIAC LIMB

Model Number	TV-IL1414120-J
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/26/2019
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.
Event or Problem Description
The patient was initially treated for an iliac aneurysm (off-label use) with the afx2 and ovation ix abdominal aortic aneurysm stents.Twenty-three (23) days post initial procedure, a type iiia endoleak with no component separation) was detected at the junction of the afx2 bifurcated stent graft and ovation ix iliac limb with no change in the diameter of the iliac aneurysm; these findings were identified during routine follow-up cta (computed topography angiography).The patient is reportedly in good condition, and the physician plans to re-intervene but surgery has not been scheduled.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type iiia endoleak was unconfirmed.Additionally, it was determined that the secondary endovascular procedure was performed on (b)(6) 2019 with non-endologix extension which was not reported.A definitive root cause for the reported type iiia endoleak could not be identified due to the lack of relevant medical imaging; however, off label - concomitant use with products outside the ifu most likely contributed to the event.The final patient status was reported being stable.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.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: b2: adverse event or product problem - updated; b5: describe event or problem - updated; g1,2: contact office- name - updated; h6: result code ¿ remove 3233; h6: conclusion code ¿ remove 11.
Event or Problem Description
The patient was initially treated for an iliac aneurysm (off-label use) with the afx2 and ovation ix abdominal aortic aneurysm stents.Twenty-three (23) days post initial procedure, a type iiia endoleak with no component separation) was detected at the junction of the afx2 bifurcated stent graft and ovation ix iliac limb with no change in the diameter of the iliac aneurysm; these findings were identified during routine follow-up cta (computed topography angiography).The patient is reportedly in good condition, and the physician plans to re-intervene but surgery has not been scheduled.Subsequent to the initial report, clinical assessment determined that secondary endovascular procedure was performed on (b)(6) 2019 with non-endologix extension.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 8829234
• Report Number: 3008011247-2019-00120
• Device Sequence Number: 11403804
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414120J1
• UDI-Public: +M701TVIL1414120J1/$$3211031FS10271835F
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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: 10/31/2021
• Device Model Number: TV-IL1414120-J
• Device Catalogue Number: TV-IL1414120-J
• Device Lot Number: FS102718-35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 07/16/2020
• 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: 2021528-010.; AFX2 BIFURCATED STENT GRAFT: 2070705-002.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR