MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-90/I20-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/21/2021
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 and two (2) medtronic (non-endologix) endurant cuffs to treat an abdominal aortic aneurysm (aaa); this procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx2 system per device ifu.It was reported that when the final angiography was performed, an intraoperative type 1b endoleak was identified.The surgeon elected to implant a gore (non-endologix) excluder leg, and another angiography was done which showed a possible type 3b endoleak.The surgeon then elected to implant another afx2 bifurcated stent graft and after a balloon touch-up, the angiography showed resolution of the endoleaks.The procedure was completed.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 reported intraoperative type iiib endoleak of the bifurcated stent graft and intraoperative type ib endoleak are confirmed.This is consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.However, the initial implant procedure was completed off-label due to concomitant use with products outside the ifu, and this may have been a contributing factor to the event.The final patient status was reported as being stable.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.G4 awareness date, h6 evaluation result codes; remove 3233, h6 evaluation conclusion codes; remove 11.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 reported intraoperative type iiib endoleak of the bifurcated stent graft and intraoperative type ib endoleak are unconfirmed.This is not consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.However, the initial implant procedure was completed off-label due to concomitant use with products outside the ifu, and this may have been a contributing factor to the event.The final patient status was reported as being stable.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.Correction: g4 awareness date.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 12288887
• Report Number: 2031527-2021-00297
• Device Sequence Number: 17266840
• Product Code: MIH
• UDI-Device Identifier: 00818009015099
• UDI-Public: (01)00818009015099(17)230519
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2021

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: 05/19/2023
• Device Model Number: BEA22-90/I20-30
• Device Lot Number: 2355330-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 08/31/2021; 09/09/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/09/2021; 09/16/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR