MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number BEA28-90/I20-30

Device Problem Fracture (1260)

Patient Problems Death (1802); Stenosis (2263)

Event Date 04/29/2017

Event Type  Death  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.

Event Description

The patient was initially implanted with an afx2 bifurcated stent graft, a suprarenal aortic extension, and an ovation ix iliac limb to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx2 system per the ifu.This patient is part of a clinical study.It was reported that there were two (2) sent fractures of the bifurcated stent graft and stenosis greater than 50%.This had occurred from the 1 year to the 3rd year follow up.It was noted that the patient had expired on (b)(6) 2020, from an unknown cause that was not related to the endologix device.No further information has been 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.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 stenosis is unconfirmed; however, the stent fracture and the death were confirmed.This is moderately consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.The patient passed away on (b)(6) 2020; however, the death causation could not be determined due to inconclusive information.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: g1/g2: contact office - name has been updated g4: date received by manufacturer has been updated h6: result code: remove code 3233 h6: conclusion code: remove code 11.

• Brand Name: AFX2
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11285963
• MDR Text Key: 230480420
• Report Number: 2031527-2021-00043
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)170804
• 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: 01/12/2021

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: 08/04/2017
• Device Model Number: BEA28-90/I20-30
• Device Lot Number: 1553666-005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL 1472867012; OVATION IX ILIAC LIMB FS070915-18; AFX VELA SUPRARENAL 1472867012; OVATION IX ILIAC LIMB FS070915-18
• Patient Outcome(s): Death
• Patient Age: 64 YR