MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-90/I16-30

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919); Compatibility Problem (2960)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Rupture (2208)

Event Date 12/21/2020

Event Type  Death  

Manufacturer Narrative

The device involved in the 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.Device was discarded at the facility.

Event Description

It was reported that during an emergent reintervention, the physician attempted to implant an afx2 bifurcated stent graft to treat an abdominal aortic aneurysm (aaa) but was unable to advance the stent graft.This procedure is outside the indications of use (off-label) due to concomitant use with products outside the ifu.The patient had undergone a previous abdominal aortic aneurysm (aaa) procedure and was implanted with two (2) non-endologix (gore) devices on an unknown date.One of the devices (non-endologix) had migrated 108mm from the renal artery and folded in (buckled) on itself causing a 1a endoleak and significant aneurysm enlargement as the graft is floating in the aorta.During the intervention, the physician made three unsuccessful attempts to position the endologix stent graft but was unable to due to the buckled stent and tortuous anatomy.On the third attempt the aneurysm ruptured and the delivery system was partially removed.An open repair procedure was attempted, however the patient suffered cardiac arrest and subsequently expired.

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 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 the difficulty in positioning the bifurcated stent graft was confirmed.This is consistent with the reported adverse event.The most likely causation for this event is due to the following contributing factors; the endovascular stents in the patient prior to the attempted additional endovascular procedure on (b)(6) 2020 were non endologix (concomitant product use condition), the aortic and iliac tortuosity (aortic angle 101 degrees, common iliac arteries were 61 and 71 degrees respectively) made implantation of the bifurcated main body stent problematic.(anatomy related) and the repeated manipulations in an attempt to position the bifurcated main body likely contributed to the rupture (user related).The procedure related harms identified were abnormal blood loss, cpr, renal vein perforation during the surgical repair, rupture and death.The patient death was determined to be procedure related.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.Corrections: g2: contact office - name has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11164320
• MDR Text Key: 226622001
• Report Number: 2031527-2021-00014
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014597
• UDI-Public: (01)00818009014597(17)220109
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

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: 01/09/2022
• Device Model Number: BEA28-90/I16-30
• Device Lot Number: 2032643008
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIFURCATED STENT GRAFT, LOT 2329669005; BIFURCATED STENT GRAFT, LOT 2366841008; BIFURCATED STENT GRAFT, LOT 2329669005; BIFURCATED STENT GRAFT, LOT 2366841008
• Patient Outcome(s): Death
• Patient Age: 72 YR