MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-60/I16-40
Medical Device Problem Codes	Use of Device Problem (1670); Device-Device Incompatibility (2919); Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and two (2) ovation ix iliac limb stent grafts to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, during a routine follow up a type 3a endoleak with complete component separation and left iliac aneurysm enlargement were identified.The patient is doing fine and is currently being monitored while an intervention is being discussed.
Additional 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.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 left iliac aneurysm enlargement, the type 3a endoleak (right common iliac artery), and the secondary endovascular procedure were confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the aneurysm enlargement and the type 3a endoleak is user-related (off-label conditions) due to concomitant use with products outside the ifu (afx2 mb with ovation limbs), as well as the off-label insertion technique/process (implanting ovation limbs before afx2 mb).The final patient status was reported as being in stable condition.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.G4 awareness date.H6 evaluation result codes; remove 3233.H6 evaluation conclusion codes; remove 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and two (2) ovation ix iliac limb stent grafts to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, during a routine follow up a type 3a endoleak with complete component separation and left iliac aneurysm enlargement were identified.The patient is doing fine and is currently being monitored while an intervention is being discussed.Additional information: a re-intervention was completed.The physician elected to implant two (2) afx vela suprarenal and two (2) ovation ix iliac limbs.The final patient status was reported to be stable.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 12185726
• Report Number: 2031527-2021-00275
• Device Sequence Number: 16517263
• Product Code: MIH
• UDI-Device Identifier: 00818009014474
• UDI-Public: (01)00818009014474(17)180728
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: BEA28-60/I16-40
• Device Lot Number: 1725263004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX ILIAC LIMB, LOT # FS071017-75.; OVATION IX ILIAC LIMB, LOT # FS071917-25.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 70 YR