MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA22-90/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263)
Date of Event	05/05/2017
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
The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.A follow up showed the patient had a potential type 2 or type 3a endoleak.The physician is planning to complete an angiogram to confirm the type of endoleak.To date an angiogram has not been completed.There have also been no reports of a secondary intervention and no additional adverse events have been reported for this patient.
Additional Manufacturer Narrative
At the completion of the investigation, based on the information clinical evaluation was able to find substantial evidence to support the following reported events; endoleak type v.Due to limited medical information available, clinical was unable to find evidence to support the reported secondary procedure.Additionally there was evidence to reasonably support the following observation; endoleak type ii of the lumbar, suboptimal juxtarenal position of the suprarenal stent resulting in stenosis of the right renal ositium, without radiographic signs of blood flow insufficiency, and without evidence of renal atrophy.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The mostly likely cause of the loss of seal could not be determined.However, there was a non device related type ii endoleak, and patent lumbar arteries present post implant (anatomy related, cautionary product use condition) changed the sac composition and caused a non critical loss of overlap without evidence of a leak.Patent lumbar arteries most likely caused or contributed to this event.There was no user, or procedure- related issue detected.There were no off-label conditions detected.Associated clinical harms included: type ii endoleak; type v endoleak; and, a secondary endovascular intervention.The final patient status was reported as doing well post repair.Incidentally, there was a stenosis of the right renal artery caused by the fabric portion of the suprarenal cuff seen at one month post implant.It was unclear if there was stent movement/migration (intra or post operatively) verses user error at implant.Currently, this suboptimal cuff position has not deterred blood flow to the kidney; there were no signs of infarction/atrophy.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.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.Correction: (b)(4).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6610429
• Report Number: 2031527-2017-00292
• Device Sequence Number: 788458
• Product Code: MIH
• UDI-Device Identifier: 00818009010223
• UDI-Public: (01)00818009010223(17)171020
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2017

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: 10/20/2017
• Device Model Number: BA22-90/I16-30
• Device Lot Number: 1265949-024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 06/04/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR