MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number BEA22-60/I13-40

Device Problem Detachment Of Device Component (1104)

Patient Problems Failure of Implant (1924); Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

Endologix became aware of an afx main body-ovation limb separation and a contained rupture of the right leg (iliac) on (b)(6) 2018 as reported by physician (b)(6) at (b)(6).How the implant separation and rupture were diagnosed and on what date are unknown.The right thoracic rupture is reported to be from nerve compression with a presumed torn artery.The patient was originally implanted with an afx2 bifurcated stent graft and ovation ix iliac limb on (b)(6) 2018 by the reporting physician.At the time of implant, it was reported that possibly there was not enough implant overlap, and the patient had inclusive disease of the aorta.During re-intervention, the patient was bridged by implanting a gore (non-endologix) limb on (b)(6) 2018 by physician (b)(6) at (b)(6).The patient's current status is unknown.

• Brand Name: AFX2
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7650368
• MDR Text Key: 112727426
• Report Number: 2031527-2018-00575
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 0081009015068
• UDI-Public: (01)0081009015068(17)180321
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2018

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
• Device Operator: Physician
• Device Expiration Date: 03/21/2018
• Device Model Number: BEA22-60/I13-40
• Device Lot Number: 1668623-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OVATION IX - ILIAC LIMB - LOT FS031617-12
• Patient Outcome(s): Required Intervention