MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA22-60/I16-40

Device Problem Device-Device Incompatibility (2919)

Patient Problem Aneurysm (1708)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.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 remains implanted.

Event Description

The patent was treated for an abdominal aortic aneurysm on (b)(6) 2023 with the implant of an afx2 bifurcated stent graft and an ovation ix iliac limb.This initial procedure is outside of the indications of use due to the use of adjunctive devices not compatible with the afx2 system.Routine follow-up performed on (b)(6) 2024 identified a type ib endoleak.Reintervention was completed on (b)(6) 2024, with the implant of two ovation ix extenders in the left common iliac; one proximal and one distal.The type ib was successfully sealed.The patient was stable post reintervention.

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 could not perform an evaluation of the device as the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type ib endoleak of the right common iliac artery and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type iiia endoleak occurred between the right internal iliac artery and right external iliac artery stents requiring perigraft arterial sac embolization (pase) that was not included in the event as reported.The type iiia endoleak was discovered during review of the operative notes dated on(b)(6) 2024.The clinical assessment also determined that there was sac growth of the right common iliac artery of 6mm occurred that was not in the event as reported.The sac growth was discovered during a review of the computed tomography scan dated on (b)(6) 2024.The complaint is most likely user related.This initial procedure is outside of the indications of use due to concomitant product usage (ovation limbs, viabahn and vbx stent in rcia).This likely contributed to the reported events.There was no abdominal aortic aneurysm.There was a reported small gutter leak at completion of the index procedure despite percutaneous transluminal angioplasty.This could have contributed to the reported event.No procedure related harms were identified.The final patient status was reported as discharged home on post operative day one.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: awareness date ¿ 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: 18713161
• MDR Text Key: 335524758
• Report Number: 3011063223-2024-00014
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• 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 Model Number: BEA22-60/I16-40
• Device Lot Number: 2729141-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (LN FS052423-01).
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male