MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA22-90/I16-30
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/21/2016
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 returned.
Event or Problem Description
During initial implant of bifurcated stent the physician had difficulty deploying the stent.The physician had trouble deploying the contra lateral limb and was not able to pull down the sure pass wire.After troubleshooting the deployment was successful.During a final angiogram run the physician identified a dissection in the right external iliac artery.An additional non-endologix stent was placed to resolve the issue.The procedure was completed and there have been no additional adverse events reported for this patient.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6278214
• Report Number: 2031527-2017-00042
• Device Sequence Number: 889149
• Product Code: MIH
• UDI-Device Identifier: 00818009010223
• UDI-Public: (01)00818009010223(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
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2019
• Device Model Number: BA22-90/I16-30
• Device Lot Number: 1423844-014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2016
• Initial Report FDA Received Date: 01/25/2017
• 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: 72 YR