MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA25-60/I16-40
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Hematoma (1884); Failure of Implant (1924); Rupture (2208); Blood Loss (2597)
Date of Event	12/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device has not been received.
Event or Problem Description
During the initial deployment of a bifurcated stent graft on (b)(6) 2016 the physician had difficulty deploying the stent.The physician performed troubleshooting steps and still was not able to complete the initial implant of the bifurcated stent.When attempting to deploy the ipsi lateral limb the inner core of the device broke and detached from the delivery system.The patient had blood loss and damage to the aortic vessel wall.The physician elected to explant the device and completed an open repair of the aneurysm.The procedure was completed and there have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the available information, the clinical evaluation was able to confirm the reported event.The clinical evaluation additionally found evidence to reasonably suggest the following contributing factors to the reported event; off label use, dual angulation in combination with the absence of an abdominal aneurysm, patient anatomy, mechanical difficulties, unsuccessful deployment, and foreign body retention.The review of the manufacturing lot confirmed all devices met specifications prior to release.The returned device evaluation was also able to confirm the reported event.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event at this time.Correction: conclusion codes and device codes updated based on device evaluation.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6265433
• Report Number: 2031527-2017-00035
• Device Sequence Number: 10783721
• Product Code: MIH
• UDI-Device Identifier: 00818009010209
• UDI-Public: (01)00818009010209(17)190624
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2016

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: 06/24/2019
• Device Model Number: BA25-60/I16-40
• Device Lot Number: 1423740-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2017
• Supplement Report FDA Received Date: 04/09/2017
• 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: Required Intervention
• Patient Age: 87 YR