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

Model Number BA28-90/I20-30

Device Problems Leak/Splash (1354); Stretched (1601)

Patient Problem Failure of Implant (1924)

Event Date 11/28/2017

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.

Event Description

The patient was initially implanted with a bifurcated stent, an infrarenal aortic extension and a non-endologix gore thoracic device.A follow up computed tomography (ct) showed the patient had a type 1a endoleak and possible dilation of the main body stent at the distal region.The physician elected to implant an additional bifurcated stent and an additional infrarenal aortic extension.During the secondary procedure the physician extended coverage by covering the sma, celiac and renal arteries.Additional non-endologix stents were implanted snorkel the covered arteries.The final patient status is unknown and not initially reported.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were substantial reported evidence that supported the following case event.Clinical confirmed the secondary endovascular procedure performed on (b)(6) 2017.The patient condition post repair was favorable.Upon refuted findings from clinical assessment, the reported type 1a was resolved, but there was a persistent gutter leak seen at the end of the repair procedure, and, one day post procedure, an indeterminate (type iii) endoleak was noted.The type 1a and stent cage dilation was not able to be confirmed by clinical due to lack of medical images.The reported implant migration/movement was not confirmed because the graft movement was related to a non-endologix device (gore).Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent graft integrity of the main body (stretched -~20%) was the use of strata material in combination with the use of non endologix products (intentional user-error) and large balloon dilation at implant.The most likely proximal loss of seal was the concomitant thoracic aneurysm (cautionary product use).Procedure-related harms included bilateral renal infarcts due to the planned, intentional covering of the renal arteries, and blood chemistry abnormalities.The patient was discharged home on the fifth post operative day with a known, persistent indeterminate endoleak.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.

Event Description

Upon refuted findings from clinical assessment, the reported type 1a was resolved, but there was a persistent gutter leak seen at the end of the repair procedure, and, one day post procedure, an indeterminate (type iii) endoleak was noted.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7153070
• MDR Text Key: 96001664
• Report Number: 2031527-2017-00704
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: Physician
• Device Expiration Date: 12/31/2013
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1101184-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2013
• 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: 73 YR