MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-90/I16-30
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Pain (1994); Ruptured Aneurysm (4436); Clinical Endoleak (4843)
Date of Event	03/14/2023
Type of Reportable Event	Death
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm and left common iliac artery aneurysm on (b)(6) 2019 with implant of an afx2 bifurcated stent graft (bsg) and an afx vela infrarenal.Due to the occlusion of the left iliac artery, an excluder leg (non-endologix) was deployed from the left common iliac artery (lcia) to the external iliac artery.An afx2 bsg was implanted via the right approach followed by placement of an afx vela infrarenal just below the renal arteries.An aneurysm was also noted in in the right common iliac artery (rcia); however, the procedure was concluded as a staged embolization of the rcia was planned but it is unknown whether the embolization was performed.On (b)(6) 2021 a follow up computed tomography (ct) scan revealed a type ib endoleak from the distal right leg and migration of the proximal stent graft.Consequently, a secondary endovascular aneurysm repair (evar) was performed using an excluder aortic extension (non-endologix) and an excluder leg (non-endologix), along with embolization of the right internal iliac artery.This event was reported in mdr # 3011063223-2026-00041.On (b)(6) 2023, the patient presented to a hospital with sudden lower abdominal pain.A ct scan revealed a retroperitoneal hematoma, and the patient was emergently transferred to the facility with a diagnosis of ruptured abdominal aortic aneurysm.No clear type i or iii endoleaks were observed on imaging, and the rupture was presumed to be caused by a type ii endoleak from the inferior mesenteric artery (ima) and lumbar arteries.Surgery was then performed consisting of aneurysm reduction and ligation of the ima and lumbar arteries by aneurysmorrhaphy.The proximal side of the aneurysm was banded, and the ima was ligated before opening the aneurysm sac.Upon incision, a type iiia endoleak was discovered at the device junction.Although the proximal aorta was occluded with an intra aortic balloon occlusion (non-endologix), the necessary additional devices to treat a type iiia endoleak had not been prepared, resulting in a prolonged waiting period.Ultimately, an excluder aortic cuff (non-endologix) was used to seal the endoleak.Postoperatively, disseminated intravascular coagulation persisted, making hemorrhage control extremely difficult.Death was confirmed in the icu later that day.The physician noted that the inability to identify the type iiia endoleak preoperatively led to an inappropriate choice of surgical technique and a lack of necessary devices.This is considered the primary factor for the difficulty in controlling the hemorrhage.Note: the afx2 system was evaluated using endologix components.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.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 that the type iiia endoleak, type ii endoleak of the internal mesenteric artery, rupture, surgical conversion and death complaints are unconfirmed.This is not consistent with the reported adverse event/incident.As the events could not be confirmed, causation could not be assigned.It was reported that the type iiia endoleak was not identified prior to the tertiary procedure, which led to an inappropriate choice of surgical technique and the absence of necessary devices.This reportedly resulted in a prolonged surgical time and subsequent disseminated intravascular coagulation, leading to uncontrolled bleeding and the patient¿s death.Concomitant use of non-endologix stents in the bilateral iliac arteries, as well as a proximal extension for reported migration (index and secondary procedure performed (b)(6) 2021), constitutes off-label use; it is unclear whether this contributed to the reported events.Revision of a previously placed graft represents a cautionary condition of use; it is also unclear whether this contributed to the reported events.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The procedure related harm identified was death.The final patient disposition was death on (b)(6) 2023 post-operatively.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.H3 other text: device remains implanted.

• 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: 24836005
• Report Number: 3011063223-2026-00042
• Device Sequence Number: 13369699
• Product Code: MIH
• UDI-Device Identifier: 00818009015136
• UDI-Public: (01)00818009015136(17)210411
• 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
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 04/11/2021
• Device Model Number: BEA22-90/I16-30
• Device Lot Number: 2239996002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• 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 INFRARENAL, LOT # 2234540009; COILS (NON-ENDOLOGIX); EXCLUDER AORTIC EXTENSION (NON-ENDOLOGIX); EXCLUDER LEG (NON-ENDOLOGIX); EXCLUDER LEG (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male