MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I20-40
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, a vela suprarenal aortic extension, two excluder (non-endologix) iliac limbs that were implanted bilaterally, and the left internal iliac artery (iia) was occluded with coils for treatment of a common iliac artery aneurysm (ciaa).It was noted that the right (iia) had been occluded prior to the endovascular aortic repair (evar).This initial procedure is outside the indications of use (off-label) due to the treatment of an ciaa and the use of adjunctive devices not compatible with afx system per the ifu.Approximately three and a half (3.5) years post initial procedure, the patient was found to have an indeterminate type endoleak and right ciaa enlargement measuring approximately 40mm.The patient is currently being monitored while an intervention is being discussed.
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 h3 other text : device remains implanted.
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 indeterminate endoleak and aneurysm (iliac) enlargement is unconfirmed due to lack of medical information surrounding the reported event.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Unable to identify the contribution factors due to lack of medical information.During the investigation, endologix found reasonable evidence to suggest the device was used off-label; however, this is an off label case - concomitant use with products outside the ifu, off label - iliac anatomy.The final patient status was reported as currently being monitored.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.

• 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: 19488971
• Report Number: 3011063223-2024-00079
• Device Sequence Number: 7024443
• Product Code: MIH
• UDI-Device Identifier: 00818009014412
• UDI-Public: (01)00818009014412(17)221204
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2024

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: 12/04/2022
• Device Model Number: BEA28-80/I20-40
• Device Lot Number: 2313761003
• 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: 05/27/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL, LOT # 2280415009; COILS (NON-ENDOLOGIX); GORE EXCLUDER ILIAC LIMB (NON-ENDOLOGIX); GORE EXCLUDER ILIAC LIMB (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male