MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA28-110/I20-30
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263)
Date of Event	12/09/2016
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.Devices remain implanted in the patient.
Event or Problem Description
It was reported the patient had an initial procedure on (b)(6) 2015 with a bifurcated stent and an infrarenal aortic extension.On (b)(6) 2016 a follow up ultra sound showed a type 3b endoleak.On (b)(6) 2016, the physician re-lined with a bifurcated stent to seal the endoleak.The subsequent endovascular procedure was completed and there have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information, the clinical evaluation was not able to confirm the reported event.The information received had sufficient evidence to support the following observations; a non-endologix stent in the proximal left iliac limb, suboptimal stent positioning in the iliac limbs, a type 2 endoleak, distal movement of the infrarenal aortic extension, prior to this reported event the patient had a previous repair with a suprarenal aortic extension and a right iliac limb extension.The clinical evaluation additionally found the following potential contributing factors to the reported event; off label use and patient anatomy.The event devices remain implanted in the patient and were not available for further evaluation.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event at this time.
Additional Manufacturer Narrative
At the completion of clinical the clinical review, based on additional information received.The clinical assessment was able to confirm a type 3b endoleak.Additionally there was narrowing of the left iliac limb where the physician placed a non-endologix limb to resolve the issue.A 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; 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.The type 3b endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at (b)(4).Since the corrective actions were implemented, the type 3b endoleak events reported for afx devices has been reduced to (b)(4).No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6221015
• Report Number: 2031527-2017-00010
• Device Sequence Number: 16245258
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214(17)171014
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 03/07/2017

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: 10/14/2017
• Device Model Number: BA28-110/I20-30
• Device Lot Number: 1283284-024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: Not provided; 10/26/2017
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 03/31/2017; 11/07/2017
• 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: AORTO UNI-ILIAC [INFRARENAL]- (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR