MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED

Model Number	BEA22-40/I13-40
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Break (1069); Difficult or Delayed Positioning (1157); Positioning Failure (1158); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Cardiopulmonary Arrest (1765); Death (1802); Failure of Implant (1924); Perforation of Vessels (2135); Blood Loss (2597)
Date of Event	12/17/2016
Type of Reportable Event	Death
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.Devices not released from the hospital.
Event or Problem Description
During initial implant of afx2 bifurcated device the physician had difficulty deploying the stent.The patient was being treated for occlusive disease and had narrow access point.When attempting to deploy the graft the stent would not open, the physician tried several techniques, including the use of a balloon and was not able to deploy the graft.In an effort to deploy the stent as the physician was pulling to the physician heard a snap and the introducer broke additional pulling caused the graft to slip into the common iliac artery.The patient had a drop in blood pressure and 400cc loss of blood.The physician made one final attempt by introducing an ovation limb and the patient went into cardiac arrest and expired.The physician indicated deployment was successful, however, there was resistance when retracting the nose cone.The physician does not believe the device was the cause of the patient death.
Additional Manufacturer Narrative
At the completion of the investigation, due to lack of medical information available for review, clinical assessment was unable to confirm the following reported event; difficult stent deployment and difficult to withdraw [intentional user error]; iliac perforation; successful iliac stent deployment (ovation); hypotension; blood loss; intraoperative cardiac arrest; and, death.The review of manufacturing lot confirmed all devices met specifications prior to release.The event device was returned for evaluation.Evaluation of the system could not determine the cause for the reported difficulty deploying the main body with the control cord.Unknown, there is not enough information available to determine the root cause of the reported event at this time.Clinical found evidence to reasonably suggest the following contributing factors to the reported event; off-label absence of an aortic aneurysm, iliac diameter out of range, patient anatomy, aortic stenosis, severe calcium.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX2
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6255067
• Report Number: 2031527-2017-00025
• Device Sequence Number: 13709861
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: (01)00818009015075(17)170512
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2016

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: 05/12/2017
• Device Model Number: BEA22-40/I13-40
• Device Lot Number: 1488577-002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2016
• Supplement Date Received by Manufacturer: 12/17/2016
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 07/14/2017
• 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: Death
• Patient Age: 74 YR