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

Model Number	BEA28-70/I16-30
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated with the afx abdominal aortic aneurysm stent on (b)(6) 2016.Approximately two (2) years post initial procedure, a main body-to-proximal extension separation was detected by ct on an unknown date, which has been defaulted to (b)(6) 2018; endologix became aware of the reported product problem on (b)(6) 2018.The physician plans to schedule the patient for re-intervention.
Event or Problem Description
Additional information received confirming that the reported implant separation was discovered by (b)(6) on (b)(6) 2018.In addition, re-intervention was completed on (b)(6) 2018 and the physician elected to treat the patient by implanting an infrarenal afx device.The clinical assessment also detected event of sac growth had occurred for the patient.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported event of type iiia endoleak with complete component separation.The clinical assessment also determined that there was evidence to reasonably suggest sac growth occurred that was not included in the event as reported.The sac growth was discovered during review of the 20month post implant ct scan.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be in stable condition post the secondary endovascular procedure.The manufacturing lot review confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3a endoleak.The root causes have been identified as; 1.Patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; 2.Patient conditions including disease progression or anatomical changes post implant; 3.Off label product use including patient anatomy, overlap length, oversizing between components, and placement of the devices within the anatomy of the patient.Endologix implemented the following corrective actions to reduce the type 3a endoleak events; 1.Sizing guidance and instructions were updated in the ifu and released on 17 jun 2015, 2.Field training was completed by 03 aug 2015.Since the corrective actions were implemented the type 3a events have been reduced significantly and are well within the acceptable range per our risk assessment.Correction: outcomes: remove other serious and add required intervention; remove result code 3233 and add 4247; remove conclusion code 11 and add 22, 4315.Additional information: add patient code 1708; add device codes 1068, 1354; add method codes 3331, 4112,.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7804542
• Report Number: 2031527-2018-00683
• Device Sequence Number: 13776360
• Product Code: MIH
• UDI-Device Identifier: 00818009014603
• UDI-Public: (01)00818009014603(17)170628
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: BEA28-70/I16-30
• Device Lot Number: 1514898-011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 11/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-VELA INFRARENAL-1614514-002.; AFX-VELA INFRARENAL-1614514-002
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 89 YR