MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-110/I20-30
Medical Device Problem Codes	Material Puncture/Hole (1504); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Aneurysm (1708); Pain (1994); Rupture (2208)
Date of Event	02/05/2020
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.Device iteration is afx2.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, a suprarenal stent graft extension and an ovation ix limb extenders to treat an abdominal aortic aneurysm (aaa).This case is outside the indications of use (off -label) due the use of afx with ovation devices.Approximately 3.5 years post initial procedure, abdominal pain and a type 3b endoleak with sac growth was reported.An intervention was completed.The physician elected to implant non- endologix (gore) stent to treat this reported event.The patient was reported as doing well post intervention.
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.At the completion of the clinical assessment, the type 3b endoleak from the distal bifurcated stent graft event, sac growth and rupture were identified.The type 3b endoleak is most likely user related due to the off-label, concomitant use of an ovation extender in the right iliac artery.The procedure related harms identified was a prolonged hospitalization.The final patient status was discharged on the sixth (6) post-operative day to a skilled nursing facility.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 afx2 corrections: h6: result remove code 3233 h6: conclusion remove code 11.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, a suprarenal stent graft extension and an ovation ix limb extenders to treat an abdominal aortic aneurysm (aaa).This case is outside the indications of use (off -label) due the use of afx with ovation devices.Approximately 3.5 years post initial procedure, abdominal pain and a type 3b endoleak with sac growth was reported.An intervention was completed.The physician elected to implant non- endologix (gore) stent to treat this reported event.The patient was reported as doing well post intervention.Additional information: during clinical investigation it was determined that there was evidence to reasonably suggest a rupture.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9783258
• Report Number: 2031527-2020-00083
• Device Sequence Number: 16315578
• Product Code: MIH
• UDI-Device Identifier: 00818009014542
• UDI-Public: (01)00818009014542(17)170512
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 05/12/2017
• Device Model Number: BEA28-110/I20-30
• Device Lot Number: 1355044-024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX EXTENDER, LOT FS021116-17; VELA SUPRARENAL, LOT 1485999023
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR