MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I20-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/01/2021
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 afx with duraply.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).Approximately 5.5 years post initial procedure, it appears that the patients aortic neck has dilated causing the bifurcated stent graft to move.The graft is no longer covering the renal arteries.There is no evidence of an endoleak.The patient is stable and being monitored.
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.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 stent graft movement and neck dilation is not a device failure of the endologix bifurcated stent graft; rather a proximal migration of a non-endologix stent with resultant neck dilation occurred.This is not consistent with the reported adverse event/incident.The most likely causation for the reported event is user-related as concomitant product use (with bilateral renal artery stents and a non-endologix proximal extension) is cautionary product use.The final patient status was reported as being stable.Therefore, this is no longer a reportable event as there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of an endologix device.Corrections: b5 describe event or problem, g4 awareness date.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).Approximately 5.5 years post initial procedure, it appears that the patients aortic neck has dilated causing the bifurcated stent graft to move.The graft is no longer covering the renal arteries.There is no evidence of an endoleak.The patient is stable and being monitored.Additional information received per clinical assessment indicating that a non-endolgix proximal extension migrated, and that no device failure of the afx bifurcated stent graft occurred.This non-endolgix extension was placed between the renal artery (non-endologix) stents and the bifurcated stent graft.Therefore, there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of an endologix device.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11728447
• Report Number: 2031527-2021-00177
• Device Sequence Number: 3895234
• Product Code: MIH
• UDI-Device Identifier: 00818009012630
• UDI-Public: (01)00818009012630(17)180612
• 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): 04/01/2021

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: 06/12/2018
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1251918003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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: Other
• Patient Age: 81 YR