MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA22-60/I13-40

Device Problems Off-Label Use (1494); Activation Failure (3270)

Patient Problem Ruptured Aneurysm (4436)

Event Date 01/16/2024

Event Type  Death  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it was retained by the hospital.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 retained by the hospital.

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft.During this initial procedure the yellow cord failed to release.This device was not implanted.It was also reported that the patient¿s aorta and iliac artery ruptured.The procedure was completed by implant of another afx2 bifurcated stent graft and an afx vela infrarenal aortic extension.The delivery system is not available for return as was retained by the hospital.

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.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 delivery system is retained by the user facility.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 yellow cord failed release graft carrying (device failed to deploy), aortic rupture, iliac rupture and death complaints are confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint are abnormal blood loss, surgical conversion (abdominal compartment syndrome), respiratory insufficiency, hemodynamic instability, prolonged procedure, rupture of right iliac artery and abdominal aorta, laceration of the left iliac artery, additional surgical procedures ((b)(6) 2024) and renal failure (continuous dialysis).This was an off-label case.The proximal aortic neck diameter is 14.9mm (should be 18-32mm).There is no abdominal aortic aneurysm sac.There were severe iliac calcifications, creating focal stenosis in the right common iliac artery of 4.0mm and the left common iliac artery of 5.2mm.This likely contributed to the reported events (user related).It was reported that the graft carrying device failed to deploy.This also likely contributed to the reported event.The hostile anatomy most likely would have made deployment of any graft problematic.The patient death was determined to be procedure and device related.The final patient status was reported as deceased on postoperative day five.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: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem has been updated.E4: initial report sent to fda has been updated.G3: awareness date has been updated.H1: type of reportable event has been updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.The user facility reported the event under voluntary mdr# mw5150643 on 19 jan 2024.

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft.During this initial procedure the yellow cord failed to release.This device was not implanted.It was also reported that the patient¿s aorta and iliac artery ruptured.The procedure was completed by implant of another afx2 bifurcated stent graft and an afx vela infrarenal aortic extension.The delivery system is not available for return as was retained by the hospital.Additional information: it was reported that the patient expired on (b)(6) 2024.

• 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: 18632089
• MDR Text Key: 334493701
• Report Number: 3011063223-2024-00011
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)261109
• 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: 01/16/2024

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/I13-40
• Device Lot Number: 2734156005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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
• Patient Outcome(s): Death; Other
• Patient Age: 73 YR
• Patient Sex: Female