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

Model Number	BEA28-120/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/17/2020
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 afx with duraply.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, a vela suprarenal stent graft, and an ovation ix extender 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 afx system per the ifu.Approximately 1 years post initial implant during a routine computerized tomography (ct) for a thoracic aneurysm the physician identified a 3b endoleak.The patient is currently is stable and an intervention has been scheduled.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, a vela suprarenal stent graft, and an ovation ix extender 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 afx system per the ifu.Approximately 1 year post initial implant during a routine computerized tomography (ct) for a thoracic aneurysm, the physician identified a type 3b endoleak.The patient is currently is stable and an intervention has been scheduled.Additional information received confirming that the patient was initially treated for a thoracic aneurysm, which is cautionary product use (off-label).Also, it was confirmed that the physician elected to treat the patient by implanting one (1) additional vela suprarenal and one (1) afx2 bifurcated stent graft on (b)(6) 2020.
Additional Manufacturer Narrative
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.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 reported type iiib endoleak is unconfirmed.The clinical evaluation also shows reasonable evidence to suggest the following off-label factors could have contributed to the reported event: concomitant product use of an ovation extender with afx/afx2 devices, a proximal neck length of 6mm at initial implant procedure (ifu requirement is greater than or equal to 15mm), and treatment of a concomitant thoracic aneurysm (ifu requirement is presence of an abdominal aortic aneurysm).However, the device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.No procedure-related harms were identified.The final patient status was discharged on the first post-operative day following a secondary endovascular repair.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.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10557991
• Report Number: 2031527-2020-00266
• Device Sequence Number: 11498242
• Product Code: MIH
• UDI-Device Identifier: 00818009014443
• UDI-Public: (01)00818009014443(17)200313
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 08/26/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2020
• Device Model Number: BEA28-120/I16-40
• Device Lot Number: 2228754008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 09/20/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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: AFX VELA SUPRARENAL - 2248993005; OVATION IX EXTENDER - FS120616-04
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 69 YR