MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C80-O20

Device Problems Hole In Material (1293); Leak/Splash (1354); Torn Material (3024)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices discarded at the hospital.

Event Description

It was reported the patient had an initial procedure with a bifurcated stent and a suprarenal aortic extension.On (b)(6) 2017 the patient presented to the hospital with abdominal pain.The physician elected to explant the devices and complete an open repair.The physician observed a large tear in the proximal stent.The patient is reported to be in stable condition.

Manufacturer Narrative

Based on the information available the root cause of the reported event is unknown.At the completion of the clinical evaluation, there was no evidence to support the following reported events: endoleak type iiib of the suprarenal proximal extension, abdominal pain, and explant with conversion to open repair.Device was not returned, therefore, sample evaluation was not completed.The manufacturing record review did not reveal any issues or deviations that would explain the reported event.The manufacturing records confirm that the lots met all requirements prior to release.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 9495984606
• MDR Report Key: 6490956
• MDR Text Key: 72743093
• Report Number: 2031527-2017-00159
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PO40002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• 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: A34-34/C80-O20
• Device Lot Number: 1025848-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2012
• 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
• Treatment: BIFURCATED STENT GRAFT- 1046784-014
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR