MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-90/I16-30

Device Problem Stretched (1601)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2018

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

The patient was previously implanted with afx devices to treat an abdominal aortic aneurysm (aaa).Approximately six (6) years post initial procedure during a routine follow-up, ct revealed an a typical appearing out-pouching of the strata graft material (dilation) just above the bifurcation; the physician determined that this is not likely a 3b endoleak as the aaa sac has shrunk significantly (from 61mm to 49mm since time of implant).Patient reported in good condition.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following observations: billowing (out-pouching) of the strata material at the bifurcation and no evidence of a type iiib endoleak of the bifurcated device.Device, user, procedure, or anatomy relatedness of this complaint could not be determined.Procedure-related harms for this complaint could not be determined.The final patient status was reported to be in good condition.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Correction: conclusion code - remove 11.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8205449
• MDR Text Key: 131701218
• Report Number: 2031527-2018-00977
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

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: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1047065-007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/30/2018
• Supplement Dates Manufacturer Received: 11/30/2018
• Supplement Dates FDA Received: 03/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-LIMB STENT GRAFT: 1039929-012; AFX-SUPRARENAL AORTIC EXTENSION: 1025772-014
• Patient Outcome(s): Other
• Patient Age: 78 YR