MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-100/I20-40

Device Problems Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017)

Patient Problem Aneurysm (1708)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event are in transit for return device evaluation; however, have not yet been received.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.H3 other text : device not yet received.

Event Description

The patient was being treated for an endovascular aneurysm repair (evar) (b)(6) 2018, with the implant of a medtronic (non-endologix) 16x20x82mm endurant leg from the right common iliac artery (cia) proximal to the cia distal.Then the afx2 bifurcated stent graft (bsg), afx vela suprarenal, and afx limb (left leg) were implanted.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.Follow-ups showed gradual aneurysm enlargement with no observed endoleaks on computed tomography.The aneurysm continued to grow, and the physician elected to explant the devices on (b)(6) 2024.During this surgery, holes were confirmed around afx2 bsg above the graft bifurcation, where the proximal edge of endurant leg was positioned.All afx devices were explanted, and vessel replacement was performed.Final patient status was not provided.

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.Endologix performed an evaluation of the returned afx2 bifurcated stent graft, and portions of the afx vela suprarenal and afx limb.The devices were returned securely packaged in a box and transported in a biohazard containment bag.The devices were decontaminated to eliminate any potential contaminants.Visual inspection of the afx2 bifurcated stent graft found punctures where the stent/stent frame protruded on the distal portion of the stent graft confirming the reported type iiib endoleak.However, it should be noted that the possibility that this damage may have occurred during the explant procedure.A visual inspection of the afx vela suprarenal and afx limb was performed.Multiple tears and holes were also observed.It's possible that some damage may have occurred during the explant procedure.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the report of aneurysm enlargement of 7.2mm and type iiib endoleak of the distal main body complaints are confirmed.The device explant complaint is unconfirmed.This is not consistent with the reported adverse event/incident.The complaint is most likely user related due to off label concomitant product use.The superior stent margin of the non endologix stent in the right common iliac artery was in the area of the type iiib endoleak.Procedure related harms could not be identified.The final patient status was not reported.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.G3: awareness date ¿ updated h3: device evaluated by manufacturer - updated h3: device returned to manufacturer for evaluation - updated h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.

• Brand Name: AFX2
• Type of Device: 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: 18768822
• MDR Text Key: 336123737
• Report Number: 3011063223-2024-00023
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2020
• Device Model Number: BEA28-100/I20-40
• Device Lot Number: 1932746-004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX LIMB (LN 1784573-002); AFX VELA SUPRARENAL (LN 1729348-002); MEDTRONIC (NON-ENDOLOGIX) ENDURANT (LN UNK)
• Patient Outcome(s): Required Intervention