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

Model Number	BA25-100/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Collapse (1099); Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the incident devices have not been received for evaluation.If the devices are received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent, a suprarenal aortic extension, and a limb extension.A follow up showed the patient had a type 3a endoleak.The physician elected to explant the devices and complete an open repair.The patient is reported to being doing well and there have been no additional adverse events reported.
Additional Manufacturer Narrative
Based on the information received at the completion of the clinical evaluation, there were reported evidence that supported the following case event.The initial report of the complaint was for a type 3a endoleak, upon clinical assessment, they refuted the reported event, and confirmed that the patient had a type 1b endoleak instead.In addition, patient also had a stent migration; a main body stent buckling; and a supra renal cuff stent buckling.Around 2 to 24 months post implant, placement of left renal artery stent for stenosis was performed.Endologix was informed by the sales rep that the physician elected to explant the devices and complete an open repair.Approximate date of the explant was (b)(6) 2017.The patient is reported to being doing well and there have been no additional adverse events reported.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the distal loss of seal was the placement of the stent in an off-label iliac anatomy (intentional user error).The most likely cause of the stent migration was the significant thrombus at the neck (cautionary product use) which resulted in an extreme anterior remodeling of the cuff with 100% stent buckling (non-flow limiting).The most likely cause of the main body stent buckling (near 100%) was the extreme cephalic angulation of the left iliac artery (off-label).Reportedly the device was explanted and the patient was in stable condition post the open repair procedure.To date there have been no reports of further negative patient sequelae.A review of manufacturing lot confirmed all devices met specifications prior to release.The devices explanted will not be returned for further evaluation.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7147496
• Report Number: 2031527-2017-00694
• Device Sequence Number: 1275591
• Product Code: MIH
• UDI-Device Identifier: 00818009014108
• UDI-Public: (01)00818009014108(17)180730
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2017

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: 07/30/2018
• Device Model Number: BA25-100/I20-40
• Device Lot Number: 1335155-002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 03/08/2018
• 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: LIMB STENT GRAFT- 1252598-030; VELA SUPRARENAL- 1252431-019; LIMB STENT GRAFT- 1252598-030; VELA SUPRARENAL- 1252431-019
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR