MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-40/I13-40
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received for evaluation.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 and/or the device has been received and evaluated, a follow-up report will be submitted.Device iteration is afx2.
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off- label) due to the patient having aortoiliac occlusive disease.During advancement of the afx2 bifurcated stent graft, there was a hard stop as challenging resistance was met preventing the transfer of the device.The device was removed, and the introducer sheath was exchanged.A new afx2 bifurcated stent graft advanced and implanted without difficulty.Final arteriogram showed good placement at the bifurcation.Segmented pressures were checked and found to be without gradient after percutaneous transluminal angioplasty of bilateral limbs.However, the patient had diminished pulses at the right extremity requiring right femoral exploration patch angioplasty and femoral embolectomy that yielded no debris.It was determined that there was inadequate closure at perclose (non-endologix) location with a localized dissection requiring surgical repair.Pulses remained diminished and felt to be artioriospasm as patients foot felt warm to touch.Patient was sent to recovery.
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 as the device was not returned to endologix for evaluation.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix does not show evidence of the reported inability to advance the bifurcated device which is an intraoperative observation.This is not consistent with the reported adverse event/incident.Procedure-related harms of this event could not be determined with the medical records available for review.During the investigation, endologix found reasonable evidence to suggest the device was used off-label due to the patient's pre-existing occlusive aorto-iliac disease and concomitatant use of a non-endologix device.The final patient status was reported under surveillance.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: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10097003
• Report Number: 2031527-2020-00157
• Device Sequence Number: 3122655
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: (01)00818009015075(17)230211
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2023
• Device Model Number: BEA22-40/I13-40
• Device Lot Number: 2331372010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR