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

Model Number BA25-100/I20-40

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 11/13/2017

Event Type  Injury  

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 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.

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
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7147496
• MDR Text Key: 95808462
• Report Number: 2031527-2017-00694
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014108
• UDI-Public: (01)00818009014108(17)180730
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 11/27/2017
• Supplement Dates FDA Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIMB STENT GRAFT- 1252598-030; VELA SUPRARENAL- 1252431-019; LIMB STENT GRAFT- 1252598-030; VELA SUPRARENAL- 1252431-019
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR