MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-70/I20-30
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Rupture (2208); Clinical Endoleak (4843)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will be returned for evaluation.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 being treated for an abdominal aortic aneurysm on (b)(6) 2024.An endurant (non-endologix) stent was implanted first just below the renal artery.The afx2 bifurcated stent graft (bsg) was then implanted from the right access.After balloon touch-up of the right common iliac artery (cia), another endurant (non-endologix) stent was implanted at the junction.The angiogram after balloon touch-up showed a type iiia endoleak and type ib endoleak on the right side.The right internal iliac artery (iia) was occluded and an afx limb was implanted in the right side.During balloon touch-up, the right cia ruptured, and the patient¿s blood pressure decreased.Angiogram showed a type iiia endoleak at afx2 bsg junction as well as at the afx limb junction.Based on the angiogram observation, graft damage was suspected for the afx limb junction endoleak.A second afx2 bsg was implanted from the right access.As the proximal and left limb portion of second afx2 did not fully expand an additional endurant (non-endologix) was implanted at the proximal portion.The physician tried to cannulate a guide wire into the left limb, but it failed.The physician decided to convert to an open surgery.Both of the afx2 bsg and afx limbs were explanted.A part of the proximal endurant (non-endologix) was not explanted, and vessel replacement was performed.The patient was moved to the intensive care unit.Reportedly, the patient expired on (b)(6) 2024.Note: this initial procedure is outside of the indications of use (off-label) as the safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.
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 returned device was completed.A visual and where possible functional analysis was performed.Based upon the analysis of the returned device, there is no evidence to suggest a quality problem/deficiency with respect to device manufacturing, design, or labeling.Endologix conducted a thorough evaluation of the 2 returned afx2 bifurcated stent grafts and the afx limb.The devices were securely packaged and transported in a biohazard containment bag.Upon initial inspection, traces of blood and tissue residue were observed on the devices.To ensure safety, the devices underwent a comprehensive decontamination process to eliminate any potential contaminants.The visual inspection of the first afx2 bifurcated stent graft revealed no punctures or tears.However, one side of the bifurcation showed signs of slight stent collapse.It is unclear whether this damage occurred during the explant procedure.The remainder of the graft was found to be intact, with no visible defects.Similarly, the visual inspection of the second afx2 bifurcated stent graft revealed no punctures or tears.An afx limb was also found within the stent graft.The side containing the afx limb showed slight collapse and damage.As with the first device, it is uncertain whether this damage occurred during the explant procedure.The rest of the graft was intact, with no visible defects.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows intraoperative type iiia endoleak (main body and right common iliac limb), type iiia endoleak aortic, type ib endoleak (right limb), right common iliac artery rupture, hypotension, graft damage and failure to fully expand (proximal and left limb portion of second main body) complaints are unconfirmed.The surgical conversion complaint is confirmed.The death complaint is unconfirmed.The explant was confirmed with product return.This is moderately consistent with the reported adverse event/incident.Sample task evaluation was not complete at time of clinical assessment.The initial procedure is off label due to concomitant product usage of non endologix stents not compatible with the afx system per device ifu.This could have contributed to the reported events but could not conclusively be determined.The significant angulation in the aorta and left common iliac artery could have contributed to the reported events but could not conclusively be determined.The patient death could not be determined due to inconclusive information.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.The final patient status was reported as deceased on postoperative day 4 on (b)(6) 2024).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.Corrections: g3: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: 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: 19797946
• Report Number: 3011063223-2024-00109
• Device Sequence Number: 7089136
• Product Code: MIH
• UDI-Device Identifier: 00818009014832
• UDI-Public: (01)00818009014832(17)261216
• 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: 2024
• Device Explanted Year: 2024
• 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): 06/25/2024

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 Model Number: BEA25-70/I20-30
• Device Lot Number: 2745416004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/04/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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 LIMB, LOT#: 2754597001.; AFX2 BIFURCATED STENT GRAFT, LOT#: 2733971005.; MEDTRONIC ENDURANT DEVICE (NON-ENDOLOGIX).; MEDTRONIC ENDURANT DEVICE (NON-ENDOLOGIX).; MEDTRONIC ENDURANT DEVICE (NON-ENDOLOGIX).
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female