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 Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the 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.¿ device remains implanted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, a infrarenal stent graft and a limb stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately, three (5) years post initial procedure, the patient presented sac growth with no identifiable leak.The physician is planning re-intervention.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, the abdominal sac growth of 9.6mm and right iliac sac growth of 9.9mm are confirmed.During the investigation, the clinical personnel identified that there was evidence to reasonably suggest at type 1b endoleak of the right common iliac artery and a small type 1a endoleak had occurred that was not initially reported.Procedure related harms, device, user, procedure or anatomy relatedness of this event could not be determined with the medical record/ images available for review.The final patient status was stable.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.¿device iteration is afx with duraply¿ corrections: b2: outcomes attributed to adverse events has been updated h6: remove result code 3233 h6: remove conclusion code 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, a infrarenal stent graft and a limb stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately, three (5) years post initial procedure, the patient presented sac growth with no identifiable leak.The procedure was completed successfully.There was no identifiable leak but the aaa has grown significantly.The patient is doing well.Additional information: the physician elected to relined the originally implanted devices with an afx2 bifurcated stent graft, afx suprarenal stent graft, and an ovation ix extender limb stent graft to resolve this event.During the review of medical images / records, a type 1b endoleak of the right common iliac artery and a small type 1a endoleak were identified.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9508911
• Report Number: 2031527-2019-00611
• Device Sequence Number: 572241
• Product Code: MIH
• UDI-Device Identifier: 00818009012630
• UDI-Public: (01)00818009012630(17)170926
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2017
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1251905003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/22/2019
• Supplement Report FDA Received Date: 07/13/2020
• 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: LIMB STENT GRAFT, LOT#1252590022; VELA INFRARENAL, LOT#1178445008
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 75 YR