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

Model Number BA25-90/I16-30

Device Problems Failure To Adhere Or Bond (1031); Partial Blockage (1065); Collapse (1099); Detachment Of Device Component (1104); Kinked (1339); Leak/Splash (1354); Occlusion Within Device (1423)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Ischemia (1942); Neurological Deficit/Dysfunction (1982); Occlusion (1984); Thrombus (2101); Stenosis (2263)

Event Date 05/13/2017

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.To date devices not recieved.

Event Description

The patient was initially implanted with a bifurcated stent, two suprarenal aortic extensions, and a limb stent.On (b)(6) 2017 the patient came in emergently and the physician identified an occlusion and the device was kinked in half.The physician elected to explant the devices and complete an open repair.The patient is reported as well post procedure.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation refuted the occlusion of the bifurcated stent and identified a type 3a endoleak with complete component separation.Additionally the patient had aneurysm sac growth, a stent collapse of the main body and stenosis caused by thrombus in the main body stent.Clinical found the most likely cause of the inadequate stent graft patency and loss of seal was related to the separation of the components due to a suspected off-label infrarenal aortic angulation, the use of multiple cuffs, and remodeling of the system over time which resulted in the disconnection as well as the horizontal position relative to the main body stent.In addition the anatomical forces most likely pressed the cuff onto the main body and collapsed the proximal main body stent.No procedure related issues contributed to this event.Additionally, the cautionary product use condition of non-compliance to post-operative surveillance likely contributed to both the endoleak and near-occlusive events.Unable to determine off-label conditions due to a lack of pre-implant imaging, although off-label infrarenal neck angulation was suspected.The review of the manufacturing lot confirmed all devices met specifications prior to release.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
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6635899
• MDR Text Key: 77392089
• Report Number: 2031527-2017-00304
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009010230
• UDI-Public: (01)00818009010230(17)180212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 05/13/2017

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: 02/12/2018
• Device Model Number: BA25-90/I16-30
• Device Lot Number: 1252264-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 08/03/2017
• Supplement Dates FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR