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

Model Number	BA25-100/I16-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Stretched (1601)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/30/2018
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.
Event or Problem Description
An afx bifurcated and a vela suprarenal extension were implanted to treat an abdominal aortic aneurysm.The 2 year routine follow-up showed the presence of a potential endoleak; however, the type of endoleak was not reported.The patient is reported to be asymptomatic and stable, and will be scheduled for a possible re-intervention to treat the endoleak.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the reported secondary procedure.Clinical was unable to find evidence to support the indeterminate endoleak and patient condition post-secondary procedure.Additionally there was evidence to reasonably support the dilation of the main body stent dilation.The most likely cause of the loss of seal could not be determined due to lack of medical information surrounding the secondary event procedure.It was suspected that the combination of an oversized cuff contributed to the compromised stent graft integrity of the main body stent (stretched 20%) and the cause of the compromised stent graft integrity could not be determined.Procedure related harms and final patient disposition could not be ascertained.To date there has been no reports of further negative patient sequelae.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: common device name.
Event or Problem Description
Ct studies: (b)(6) 2015; (b)(6) 2018.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7299638
• Report Number: 2031527-2018-00130
• Device Sequence Number: 13692564
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)180408
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/08/2018
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1252304024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 04/25/2018
• 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: VELA SUPRARENAL-LOT: 1252475-006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR