MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I16-40
Medical Device Problem Codes	Collapse (1099); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the 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.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately there (3) years post initial procedure, (exact date was not provided) a type 3b endoleak with sac growth was identified.An intervention was completed.The physician elected to reline the original implanted devices with an afx2 bifurcated stent graft, a vela suprarenal stent graft extension and two (2) ovation ix iliac limbs to resolve this reported event.The patient was reported as doing well post intervention.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately there (3) years post initial procedure, (exact date was not provided) a type 3b endoleak with sac growth was identified.An intervention was completed.The physician elected to reline the original implanted devices with an afx2 bifurcated stent graft, a vela suprarenal stent graft extension and two (2) ovation ix iliac limbs to resolve this reported event.The patient was reported as doing well post intervention.Additionally, clinical assessment determined there was evidence to reasonably suggest a type 2 endoleak of the lumbar (non device related failure) and distal stent buckling of the bifurcated stent graft.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported sac growth of 6mm and type iiib endoleak of the bifurcated stent graft were confirmed.Additionally, there was evidence to reasonably suggest a type ii endoleak of the lumbar (non device related failure) and distal stent buckling of bifurcated stent graft.The sac growth was likely related to the type iiib endoleak.The type iiib endoleak and stent buckling of the bifurcated stent graft causation was indeterminate.Device, user, procedure or anatomy relatedness of these events could not be determined.The final patient status was discharged on the second post operative day stable home following a secondary endovascular procedure.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.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.Device iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8874466
• Report Number: 2031527-2019-00360
• Device Sequence Number: 2754809
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049(17)171212
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2017
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1252327-017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL, LOT 1252088016; VELA SUPRARENAL, LOT 1252088016
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR