MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED

Model Number BA28-80/I16-40

Device Problem Insufficient Information (3190)

Patient Problem Test Result (2695)

Event Date 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

Endologix continues to investigate the reported event.Endologix will submit a supplemental report in accordance with 21 cfr 803.56 when additional info becomes available.Additional devices: model: a34-34/c100-o20; suprarenal aortic extension; lot: 1050126-017; release date: 07/10/2012; expiration date: 05/30/2015.

Event Description

It was reported the pt initial implant was on (b)(6) 2012.Reportedly, the pt developed a possible endoleak.A computed tomography scan revealed abnormal lobular enhancement seen at the left posterolateral periphery of the endograft repair in the aneurysm sac.No clear leak origin is identified and the location may suggest a type iii endoleak rather than a type ii endoleak.Since the aaa has not increased in size the physician has elected to rescan and evaluate in three months.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; irvine CA 92618
• Manufacturer Contact: henry ; 2 musick ; irvine, CA 92618 ; 8009832284
• MDR Report Key: 5010427
• MDR Text Key: 24672424
• Report Number: 2031527-2015-00319
• 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: company representative,health
• Reporter Occupation: Physician
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2015
• Device Model Number: BA28-80/I16-40
• Device Lot Number: 1050698-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2012
• 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
• Patient Age: 77 YR