MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-90/I20-30

Device Problems Material Puncture/Hole (1504); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 07/14/2023

Event Type  Injury  

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.

Event Description

The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years after the initial procedure, it was reported that the two components are moving away from each other.The patient underwent a re-intervention where the physician opted to proceed with an implant of an afx vela infrarenal.The final patient status remains unknown as it was not made available to endologix.

Manufacturer Narrative

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.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 reported afx2 implant movement is unconfirmed.The additional endovascular procedure complaint is confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type iiia endoleak of the aortic components and a type iiib endoleak of the distal main body also occurred.The type iiia and type iiib endoleaks were discovered on (b)(6) 2023, during a review of the computerized tomography (ct) scan performed prior to the secondary intervention on (b)(6) 2023.It was also noted that the infrarenal angle was 68.8° and this likely contributed to the type iiia endoleak; it is unclear if aortic remodeling occurred (per the infrarenal angle) due to a lack of comparative imaging.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The final patient status remains unknown.The final patient status was not made available to endologix.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: b5: describe event or problem.G3: awareness date.H6: health effect - clinical code; remove 1924.H6: investigation finding codes; remove 3233.H6: investigation conclusion codes; remove 11.

Event Description

The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years after the initial procedure, it was reported that the two components are moving away from each other.The patient underwent a re-intervention where the physician opted to proceed with an implant of an afx vela infrarenal.The final patient status remains unknown as it was not made available to endologix.Additional information: the clinical evaluation shows reasonable evidence to suggest a type iiia endoleak of the aortic components and a type iiib endoleak of the distal main body also occurred.The type iiia and type iiib endoleaks were discovered on (b)(6) 2023, during a review of the computerized tomography (ct) scan.

Manufacturer Narrative

The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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.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 reported afx2 implant movement is unconfirmed.The additional endovascular procedure complaint is confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type iiia endoleak of the aortic components and a type iiib endoleak of the distal main body also occurred.The type iiia and type iiib endoleaks were discovered on (b)(6) 2023, during a review of the computerized tomography (ct) scan performed prior to the secondary intervention on (b)(6) 2023.It was also noted that the infrarenal angle was 68.8° and this likely contributed to the type iiia endoleak (anatomy-related); it is unclear if aortic remodeling occurred (per the infrarenal angle) due to a lack of comparative imaging.Procedure-related harms and device, user, procedure, or anatomy-relatedness of the type iiib endoleak could not be determined with the medical records available for review.The final patient status remains unknown.The final patient status was not made available to endologix.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: h6 investigation finding codes; remove 3207.

• 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: 17393803
• MDR Text Key: 319835190
• Report Number: 2031527-2023-00191
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)200621
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2020
• Device Model Number: BEA28-90/I20-30
• Device Lot Number: 2261609-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• 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 VELA SUPRARENAL 2300430003.
• Patient Outcome(s): Required Intervention