MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I16-30
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft an afx infrarenal extension, an express sd (non-endologix), and an endurant (non-endologix).This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.Reportedly, due to the patient's short proximal neck the snorkel technique was used for this procedure.The express sd stent was deployed, then the endurant cuff was deployed on the proximal side via left access.The afx2 bifurcated stent graft was then deployed.Post deployment there was almost no overlap between the endurant cuff and the afx2 bifurcated stent graft.The afx infrarenal extension was deployed to bridge the two devices.Balloon touch up was performed; however, a residual type iiia endoleak remained.The physician elected to end the procedure and anticipated the type iiia endoleak would cease with medication (protamine).The patient was reported to continue to be monitored.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the intraoperative type iiia endoleak at the bifurcated stent graft and non-endologix proximal stent is confirmed from the still images.This is consistent with the reported adverse event/incident.The most likely causation for the intraoperative type iiia endoleak is user related due to the neck anatomy in addition to the concomitant use with products outside the ifu.The final patient status was reported as being expired post reintervention (reported under mfr# 2031527-2022-00025).No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx2.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 13416911
• Report Number: 2031527-2022-00024
• Device Sequence Number: 5232563
• Product Code: MIH
• UDI-Device Identifier: 00818009014597
• UDI-Public: (01)00818009014597(17)201112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 11/12/2020
• Device Model Number: BEA28-90/I16-30
• Device Lot Number: 2010138003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: AFX INFRARENAL EXTENSION (LN 2239246003); ENDURANT CUFF (NON-ENDOLOGIX) (LN UNK); EXPRESS SD STENT (NON-ENDOLOGIX) (LN UNK)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male