MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-100/I20-40
Medical Device Problem Codes	Fracture (1260); Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
Patient was initially implanted with a bifurcated, suprarenal, and limb graft in 2015.Patient presented recently with an endoleak type iiib.The physician plans to reline and procedure is scheduled for (b)(6) 2018.No additional patient sequalae has been reported at this time.
Event or Problem Description
Patinet secondary procedure has been pushed back from (b)(6) 2018 to (b)(6) 2018.
Additional Manufacturer Narrative
At the completion of the investigation, the reported endoleak type iiib of the main body is confirmed.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was not reported.There were also evidence to evidence to reasonable suggest strut fractures in the left distal main body stent occurred that was not included in the event as reported.The strut fractures were discovered during review of the 39 month post implant ct scan.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; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place (b)(6) 2014.The type iiib endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at 2.5%.Since the corrective actions were implemented, the type iiib endoleak events reported for afx devices has been reduced to less than 0.2%.Root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b endoleak events; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place (b)(6) 2014.The type 3b endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at 2.5%.Since the corrective actions were implemented, the type 3b endoleak events reported for afx devices has been reduced to less than 0.2%.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot 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.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7658735
• Report Number: 2031527-2018-00579
• Device Sequence Number: 2514729
• Product Code: MIH
• UDI-Device Identifier: 00818009014108
• UDI-Public: (01)00818009014108(17)180114
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2018

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: Physician
• Device Expiration Date: 01/14/2018
• Device Model Number: BA25-100/I20-40
• Device Lot Number: 1310988002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/30/2018
• 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: AFX-LIMB-LOT: 1253182003; AFX-SUPRARENAL-LOT: 1283063004; AFX-LIMB-LOT: 1253182003; AFX-SUPRARENAL-LOT: 1283063004
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR