MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX SYSTEM

Model Number A25-25/C55

Device Problem Material Rupture (1546)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2015

Event Type  Injury  

Event Description

It was reported that during an initial implant of a n infrarenal aortic extension and a bifurcated device, the patient ruptured intraoperatively.The physician implanted another infrarenal aortic extension which was thought to have resolve the rupture.On (b)(6) 2015 it was discovered the proximal aorta was dissected.On (b)(6) 2015, physician performed an aorto bi-iliac procedure and decided to explant the devices.The patient was reported to have done well and was discharged home.

Manufacturer Narrative

Endologix continues to investigate the reported event.Endologix will submit a supplemental report in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

Based upon the investigation findings, the reported event has been inconclusive.The explants were not returned for evaluation.A manufacturing record review was performed.The lot met all release criteria with no related ncmrs.The lot usage history shows that no other units from this lot have been involved in any similar complaints at this time.The product fmeas have been reviewed and confirmed that the risk has been accurately captured in the design fmea.The use fmea will be updated in the next revision and tracked through the quality system function.The product labeling has been reviewed and confirmed that the reported event is adequately captured in the existing labeling.Based upon the investigation findings, the root cause could not be determined based upon available information.However, product use was incongruent with the ifu due to: the absence of an abdominal aortic aneurysm and the presence of aorto-iliac stenosis, with focal aortic luminal diameters as severe as 4 mm.Those severe conditions most likely contributed to this event.Cautionary product use conditions that might have contributed to this event included: mild thrombus and calcifications at the aortic neck.A history of peripheral vascular disease and berger's disease most likely contributed to the post-operative thromboembolism.

• Brand Name: AFX SYSTEM
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: henry to ; 2 musick; irvine, CA 92618 ; 9495984772
• MDR Report Key: 4855822
• MDR Text Key: 5807783
• Report Number: 2031527-2015-00227
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown,unknown
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 07/18/2017
• Device Model Number: A25-25/C55
• Device Lot Number: 1267817-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2015
• Date Device Manufactured: 08/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR