MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I20-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Product Quality Problem (1506); Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remains implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately four (4) years post initial procedure, a type iiib endoleak (hole in graft) was detected during routine follow-up.The physician elected to treat the patient by relining with a gore (non-endologix) graft on (b)(6) 2019.The patient was reportedly in good condition pre- and post-secondary procedure.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the reported event of a type iiib endoleak due to a lack of relevant contrasted imaging.The clinical assessment determined aneurysm sac growth (14mm) of the right side common iliac artery occurred that was not in the event as reported; the sac growth was discovered during a review of the 46-month post ct scan.In addition, clinical identified that the initial implant was off-label due to no abdominal aortic aneurysm (aaa) sac present and only a right common iliac artery (rcia) sac, and placement of the stent into a pre-existing surgical tube graft repair.The procedure-related harms and the device, user, procedure, or anatomy-relatedness of the event could not be determined.The final patient status was reported to be in good condition post secondary endovascular repair.The manufacturing lot review confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.Device iteration is afx with duraply.
Event or Problem Description
The initial implant was off-label due to non-abdominal aortic aneurysm treatment (only a right side common iliac artery aneurysm sac) and placement of stent into a pre-existing surgical tube graft repair.In addition, clinical identified that aneurysm enlargement was also present at the time of the reported event.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8474044
• Report Number: 2031527-2019-00148
• Device Sequence Number: 1515891
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)180303
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 03/03/2018
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1319586-006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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-LIMB STENT GRAFT: 1252562-004; AFX-LIMB STENT GRAFT: 1252601-001; AFX-LIMB STENT GRAFT: 1252562-004; AFX-LIMB STENT GRAFT: 1252601-001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR