MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I20-13/C88F SA
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/20/2019
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 treated for an abdominal aortic aneurysm (aaa) with the intuitrak abdominal aortic aneurysm stent.Approximately 4 years post initial procedure the patient presented with a 1b endoleak and physician elected to treat with a limb extension.This event was reported under mfr #2031527-2015-00424.Now, approximately 4.5 years post intervention, the patient presented with enlarged iliac aneurysms (unknown diameter) during follow-up as detected by non-contrast ct (computed tomography).The physician elected to reline with a bifurcated stent graft, a proximal extension and a non-endologix device (vbx 8x59).Patient is doing fine.
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 left common iliac sac growth event was confirmed.This event is most likely user related due to the left common iliac artery diameter was 4.5cm (off label diameter).Procedure related harms for this event could not be determined.The final patient status was reported to be doing fine.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: h6: remove result code 3233.H6: remove conclusion code 11.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9508909
• Report Number: 2031527-2019-00612
• Device Sequence Number: 11438824
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)180304
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 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: 03/04/2018
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1252608-003
• 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: BIFURCATED STENT GRAFT, LOT# W10-3795-013; INFRARENAL AORTIC EXTENSION, LOT# W11-0665-011; INTUITRAK LIMB EXTENSION, LOT# W10-3006-006; INTUITRAK LIMB EXTENSION, LOT# W11-0580-006; LIMB EXTENSION, LOT# W10-4103-029
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR