MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted devices involved in this event have not be returned for evaluation.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent, gore (non-endologix) leg device, and bare (non-endologix) stent (off-label use with non-concomitant devices).Approximately three (3) years post initial procedure, an aneurysm expansion (unknown diameter) was observed during routine follow-up.The physician elected to treat the patient by open surgery on (b)(6) 2019, during which a type iiib endoleak was observed at the afx bifurcation.A y-graft replacement was then successfully performed and the patient was reportedly recovering in the hospital.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Correction: b1, e1 hospital name, g1-2 contact office, g4, h6; h6 device code - remove 1506 h6 result code - remove 3233 h6 conclusion code - remove 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8795288
• Report Number: 2031527-2019-00317
• Device Sequence Number: 11218253
• Product Code: MIH
• UDI-Device Identifier: 00818009010018
• UDI-Public: (01)00818009010018(17)181112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: 11/12/2018
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 1282509-007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 03/03/2020
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX SUPRARENAL AORTIC EXTENSION: 1389167-020; BARE STENT (NON-ENDOLOGIX); GORE (NON-ENDOLOGIX) EXCLUDER LEG; AFX SUPRARENAL AORTIC EXTENSION: 1389167-020; BARE STENT (NON-ENDOLOGIX); GORE (NON-ENDOLOGIX) EXCLUDER LEG
• Outcome Attributed to Adverse Event: Required Intervention