MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I16-40
Medical Device Problem Codes	Leak/Splash (1354); Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
The patient was readmitted to the hospital three (3) years post op for abdominal pain and has gi issues/ileaus and infection.The cta showed aaa size ( 11cm ) and evidence of a potential type ia/ib and type ii endoleak.As of the date of this report there have been no additional patient sequelae reported and there are no plans for a re-intervention.Reference mdr 2031527-2016-00120 for previously reported type ia endoleak and re-intervention and mdr 2031527-2017-00256 for previously reported type ib endoleak and re-intervention.
Additional Manufacturer Narrative
The type ia endoleak of the non endologix aortic cuff and the type ib endoleak of the right common iliac artery, along with sac growth of the rt iliac and aorta are confirmed.The type ia endoleak will not be addressed, as the last cuff was a non endologix component.This complaint is most likely user related due to off label iliac arteries.Procedure related harms and the final patient disposition could not be determined; it was reported that the patient was transferred to another facility for other bowel perforation/infection.The clinical assessment determined that there was evidence to reasonable suggest at implant - persistent el1a (last angiogram run).35 months post implant - stent cage dilation of the original cuff (23%); stent buckling of the main body stent just above the bifurcation; revascularization of the rt hypogastric (post coiling) with right iliac sac growth.These findings were discovered on (b)(6) 2018, during the review of the ct scan, 35 months post implant.The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7997897
• Report Number: 2031527-2018-00799
• Device Sequence Number: 16490635
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2018
• Device Model Number: BA28-100/I16-40
• Device Catalogue Number: BA28-100/I16-40
• Device Lot Number: 1252331018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 12/31/2018
• 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-(B)(4); LIMB STENT GRAFT-(B)(4); VELA INFRARENAL-(B)(4); VELA SUPRARENAL-(B)(4); VELA SUPRARENAL-(B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR