MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA25-60/I16-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Difficult or Delayed Positioning (1157); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Rupture (2208)
Date of Event	12/12/2016
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.Devices have not been received.
Event or Problem Description
Patient was being treated for a right common iliac artery (rcia) aneurysm and was initially implanted with a non-endologix stent in the rcia.After the placement of the non-endologix stent the physician deployed the afx bifurcated stent.During the deployment of the bifurcated stent the physician had difficulty advancing the guide wire through the lumen of the sure pass wire.The physician had to cut the peripheral end of the sure pass wire and the guide wire was inserted without difficulty.Once the bifurcated device was deployed the physician completed a balloon touch up.The final run angiogram identified a ruptured left common iliac artery (lcia).The physician implanted two additional non-endologix limb extensions to repair the rupture.A type 1b endoleak remained following the repair and the physician elected to complete an open repair of the lcia to seal the endoleak.The procedure was successful and there have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, the following events were reported but could not be substantiated by medical records or images; failure to insert of 0.014'' wire into the surepass due to blockage, left common iliac artery rupture with open surgical repair.The following addition events were reported; non-endologix stent placed into the right common iliac artery extending to the right external iliac artery, ballooning of the bifurcated graft, 2 iliac limb extensions placed to treat the ruptured left common iliac without success.The clinical assessment was based on no patient medical records, and no patient images.Based on the information available the root cause of the reported event is seems to be a use error.Clinical found evidence to reasonably suggest the following contributing factors to the reported event; reported fragile condition of the artery along with the ballooning of the left iliac limb.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6244147
• Report Number: 2031527-2017-00013
• Device Sequence Number: 710546
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2016

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: 1423740-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 06/23/2017
• 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: NON-ENDOLOGIX LIMB EXTENSION- LCIA; NON-ENDOLOGIX LIMB EXTENSION- LCIA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR