MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX SYSTEM; INFRARENAL BIFURCATED STENT GRAFT

Model Number BA25-100/I16-40

Device Problems Hole In Material (1293); Leak/Splash (1354); Material Rupture (1546)

Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924); Rupture (2208)

Event Date 04/29/2015

Event Type  Injury  

Event Description

It was reported that approximately 36 months post implant of a bifurcated device, a suprarenal aortic extension and an infrarenal aortic extension, the patient presented emergently to the hospital emergency room.The hospital performed a computed tomography scan which indicated the patient had an endoleak and rupture.The physician elected to correct the endoleak by explanting the devices.The patient was reported to be doing well post procedure.

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 clinical evaluation, the reported type ilib endoleak is confirmed.The explants were not available for evaluation.A manufacturing record review was performed, the lot met all release criteria with no related issues or deviations that would explain the reported event.The lot usage history showed all units have been consumed and no other units from this lot were involved in any similar event.The product labeling was 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, the patient's use of antiplatelet therapy might have contributed to this event due to its known increased risk of bleeding complications.

• Brand Name: AFX SYSTEM
• Type of Device: INFRARENAL BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: henry to ; 2 musick; irvine, CA 92618 ; 9495984772
• MDR Report Key: 4842361
• MDR Text Key: 5868947
• Report Number: 2031527-2015-00180
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2012
• Device Model Number: BA25-100/I16-40
• Device Lot Number: W11-5018-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR