MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA28-70/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Leak/Splash (1354); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Stroke/CVA (1770); Failure of Implant (1924); Ischemia (1942); Necrosis (1971); Renal Failure (2041); Thrombosis (2100); Rupture (2208)
Date of Event	01/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices discarded at the hospital.
Event or Problem Description
It was reported the patient had an initial implant on (b)(6) 2014 with a bifurcated stent, a suprarenal aortic extension, and an infrarenal aortic extension.On (b)(6) 2017 the patient came in emergently to the hospital and the physician identified a type 3a endoleak with component separation.The physician elected to explant the devices.The subsequent endovascular procedure was completed and there have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
(b)(4).Based upon the information available, the root cause of the type 3a endoleak and subsequent explant is unknown.At the completion of the clinical evaluation, the following were confirmed: endoleak type iiia and explant.Additionally there was evidence to reasonably support the following observations: left external iliac artery stent placement due to stenosis in the vessel, pain, aortic rupture and retroperitoneal hematoma treated with a surgical bypass, left common femoral artery thrombectomy, left common femoral artery endarterectomy and patch angioplasty, left external iliac artery stenosis, acute renal failure and temporary dialysis catheter, cerebrovascular accident, and wound debridement and necrotic muscle removed.The manufacturing lot record evaluation confirmed all devices met specifications prior to release.Device was not returned, therefore no physical evaluation was completed.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6299205
• Report Number: 2031527-2017-00050
• Device Sequence Number: 780234
• Product Code: MIH
• UDI-Device Identifier: 00818009010117
• UDI-Public: (01)00818009010117(17)170708
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2017

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: 07/08/2017
• Device Model Number: BA28-70/I16-30
• Device Lot Number: 1262200-023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 07/11/2017
• 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: AORTO UNI-ILIAC [INFRARENAL]- (B)(4); AORTO UNI-ILIAC [SUPRARENAL]- (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR