MAUDE Adverse Event Report: ENDOLOGIX INTUITRAK; BIFURCATED STENT GRAFT

Model Number	BA28-70/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Leak/Splash (1354)
Health Effect - Clinical Codes	Failure of Implant (1924); Heart Failure (2206)
Date of Event	09/11/2017
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
The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.A follow up showed the patient had a type 3a endoleak with component separation.The patient is scheduled for a secondary procedure.The patient is reported to be asymptomatic and in stable condition.There have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, a clinical assessment was able to confirm the type 3a endoleak with complete component separation.Additionally the clinical assessment identified the patient had a rupture prior to the initial implant which possibly contributed to the pulmonary edema and extended hospitalization following the initial repair procedure.The most likely cause of the type 3a endoleak with component separation is unknown, however it is likely the tortuous aortic anatomy and subsequent remodeling contributed to this event.The most likely cause of the complete component separation was also unknown, but it was likely that the non contrasted surveillance contributed to this event (cautionary product use condition).The devices remain implanted in the patient and were not available for further review.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.
Event or Problem Description
The physician completed a secondary procedure on (b)(6) 2017.The physician elected to implant an additional bifurcated stent and a suprarenal aortic extension to seal the endoleak.Correction, after completing a lot history review it was identified the implanted stent was an intuitrak bifurcated stent and not an afx bifurcated device.

• Brand Name: INTUITRAK
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6935871
• Report Number: 2031527-2017-00515
• Device Sequence Number: 13709660
• Product Code: MIH
• UDI-Device Identifier: 00818009010117
• UDI-Public: (01)00818009010117(17)180105
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/11/2017

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: 01/05/2018
• Device Model Number: BA28-70/I16-30
• Device Lot Number: 1295169-010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR