MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-70/I16-30
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/04/2020
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.Device remains implanted.
Event or Problem Description
During the initial implantation of the an afx2 bifurcated stent graft and suprarenal proximal extension, an intraoperative 1a, 3b and 3a endoleaks were reported.The patient had a non- endologix (gore/ excluder leg) stent implanted in the common iliac artery first.This is outside the outside the indications of use due to the use of non- endologix devices.The afx2 bifurcated stent graft and the suprarenal proximal extension was then implanted.An angiogram after balloon touch-up showed a type ia endoleak; therefore, a non- endologix (gore/ excluder cuff) stent was implanted to resolve this leak.A type 3a endoleak was confirmed from the left side.A non- endologix (gore/ excluder leg) stent was also added to resolve this leak.Another endoleak was observed above the terminal aorta, and it was suspected as a type 3b endoleak.Additional intervention was not performed, and the patient will be monitored.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported intraoperative type ia, type iiia and type iiib endoleaks was unconfirmed as the limited imaging provided could not determine if the reported endoleak identified as a type iiib was a type iiib or a type ii endoleak.A definitive root cause for the reported events could not be determined; however, it should be noted that the left common iliac artery was off label at 24.1mm diameter (should be 10-23mm), there were also non endologix stents placed in the left common iliac artery and proximal neck (off label concomitant product use), and the neck diameter was off label at 32.4mm (should be 18-32mm).Device relatedness of this event could not be determined.The final patient status was under surveillance.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.Device iteration is afx2.Corrections: d4: lot number, updated.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9777821
• Report Number: 2031527-2020-00080
• Device Sequence Number: 2511989
• Product Code: MIH
• UDI-Device Identifier: 00818009014603
• UDI-Public: (01)00818009014603(17)221024
• Combination Product (Y/N): N
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 10/24/2022
• Device Model Number: BEA28-70/I16-30
• Device Lot Number: 2301607002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 06/19/2020
• 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: GORE (NON -ENDOLOGIX) EXCLUDER LEG; GORE (NON-ENDOLOGIX) EXCLUDER(PLA280300J); GORE (NON-ENDOLOGIX) EXCLUDER(PLA280300J); SUPRARENAL EXTENSION, LOT 1685019001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR