MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA22-90/I16-30

Device Problems Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Physical Resistance (2578)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

The device involved in this event is anticipated for returned but has not been received for evaluation.If additional information pertinent to the incident is obtained, a follow up report will be submitted.

Event Description

It was reported that on (b)(6) 2017, the patient was implanted with an afx bifurcated device for an abdominal aneurysm.During the deployment of the contralateral limb, resistance was felt, the physician continued to pull the surpass wire and it was removed from the body.However, it was noted that the contralateral limb covered was still attached to the stent graft and the contralateral limb was not completely deployed.A snare catheter was inserted and the cover was removed from the main body to successfully deploy the main body.The surepass wire was removed and inspected, it was confirmed that the proximal bead was missing.The cuff was implanted without issue.There have been no patient sequelae reported.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were no substantial evidence to support the following reported events; resistance pulling the surepass wire, and detachment of the contralateral limb cover.This event included a patient involvement.A clinical assessment was required, but no medical information was provided.This assessment was based upon the reported event, cumulative knowledge informed by past assessments of similar complaints, and/or other non-medical, relative information such as, but not limited to: still photographs; videos; sizing/case planning sheet/summary.The most likely cause of the detachment of the component and the sure-pass wire issue could not be determined due to lack of relevant medical information.Unable to determine procedure-related, anatomy-related and user-related issues, off label, or cautionary product use conditions.Associated clinical harms for this event included: no known impact to the patient.The final patient disposition was unknown however there have been no additional negative patient sequelae reported.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.(b)(4).

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984606
• MDR Report Key: 6817903
• MDR Text Key: 83536096
• Report Number: 2031527-2017-00427
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009010223
• UDI-Public: (01)00818009010223(17)200407
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

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: Physician
• Device Expiration Date: 04/07/2020
• Device Model Number: BA22-90/I16-30
• Device Lot Number: 1674432-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2017
• 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: AFX-CUFF/EXTENSION-LOT: INFO NOT RECEIVED
• Patient Outcome(s): Other