MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I20-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/21/2021
Type of Reportable Event	Death
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 a bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Following the initial implant the patient had a type 2 endoleak, a secondary endovascular procedure was not completed, and the physician elected to monitor the patient.Approximately one (1) year post initial procedure a follow up showed aneurysm sac growth and a potential type 1b endoleak.The physician elected to extend the right iliac artery and implant an infrarenal aortic extension into the right common iliac to seal the endoleak.The patient is stable.This event was previously reported under mdr # 2031527-2016-00536.Endologix then became aware of an increased abdominal aortic aneurysm sac and suspicious endoleak based on the diagnosing cta scan.The patient was asymptomatic.This event was previously reported under mdr # 2031527-2018-00548.Now, approximately four and half (4.5) years post initial procedure, the patient presented with a ruptured aneurysm due to an indeterminate endoleak.The physician elected to implant another bifurcated stent graft and two (2) ovation iliac extenders to resolve this event; however, the patient passed away two days later.
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.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 that the indeterminate endoleak was identified as a type ib endoleak from the left iliac limb.The ruptured abdominal aortic aneurysm (aaa) and death are confirmed.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.Procedure related harms identified was patient expired on (b)(6) 2021.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 afx with duraply corrections: g1,2: contact office- name has been updated.G4: date received by manufacturer - updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Following the initial implant the patient had a type 2 endoleak, a secondary endovascular procedure was not completed, and the physician elected to monitor the patient.Approximately one (1) year post initial procedure a follow up showed aneurysm sac growth and a potential type 1b endoleak.The physician elected to extend the right iliac artery and implanted an infrarenal aortic extension into the right common iliac to seal the endoleak.The patient is stable.This event was previously reported under mdr # 2031527-2016-00536.Endologix then became aware of an increased abdominal aortic aneurysm sac and suspicious endoleak based on the diagnosing computed tomography angiogram (cta) scan.The patient was asymptomatic.This event was previously reported under mdr # 2031527-2018-00548.Now, approximately four and half (4.5) years post initial procedure, the patient presented with a ruptured aneurysm due to an indeterminate endoleak.The physician elected to implant another bifurcated stent graft and two (2) ovation iliac extenders to resolve this event; however, the patient passed away two days later.Additional information: the reported indeterminate endoleak was identified as a type 1b endoleak from the left iliac limb.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11809275
• Report Number: 2031527-2021-00202
• Device Sequence Number: 3634733
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)180827
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 08/27/2018
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1315861022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 07/20/2021
• 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: INFRARENAL AORTIC EXTENSION: LOT # 1319308003; SUPRARENAL AORTIC EXTENSION: LOT # 1252470019; INFRARENAL AORTIC EXTENSION: LOT # 1319308003; SUPRARENAL AORTIC EXTENSION: LOT # 1252470019
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 86 YR