MAUDE Adverse Event Report: ENDOLOGIX AFX

Model Number BA22-70/I16-30

Device Problems Failure To Adhere Or Bond (1031); Bent (1059); Occlusion Within Device (1423)

Patient Problems Failure of Implant (1924); Thrombus (2101)

Event Date 06/12/2015

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional info pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

It was reported post implant of a bifurcated device and a suprarenal aortic extension a computed tomography scan revealed a small amount of intraluminal thrombus with the lumen.There was no endoleak detected., there was however a possible fracture and 70 degree angulation that developed.The physician elected to implant an infrarenal aortic extension.The patient is reported to be doing well.

Manufacturer Narrative

Based upon the clinical assessment, a type iiia endoleak was confirmed along with a possible type ii endoleak.The reported stent fracture could not be substantiated with the available info.A mfg record review was performed and the lot met all release criteria with no issues or deviations that would explain the reported event.The root cause of the type iiia endoleak could not be determined with the limited available info.There was a possible type ii endoleak that could have contributed to the event.It is inconclusive whether a design or mfg issue contributed to the event, and overall, the investigation is inconclusive.

• Brand Name: AFX
• Manufacturer (Section D): ENDOLOGIX; irvine CA 92618
• Manufacturer Contact: henry to ; 2 musick ; irvine, CA 92618 ; 8009832284
• MDR Report Key: 5194440
• MDR Text Key: 30218265
• Report Number: 2031527-2015-00426
• 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
• Type of Report: Initial,Followup
• Report Date: 06/17/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: BA22-70/I16-30
• Device Lot Number: 1047026-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR