MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-120/I20-40

Device Problems Hole In Material (1293); Leak/Splash (1354); Stretched (1601); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The initial procedure was performed on (b)(6) 2017.Patient was implanted with a vela infrarenal, afx2 bifurcated stent and an ovation iliac extension was implanted inside the right limb of the afx2 bifurcated.On an unknown later date of the planned stepped procedure, a non-endologix graft was implanted.On (b)(6) 2018, a computerized tomography revealed a 3b endoleak in the main body of the afx2 bifurcated stent.On (b)(6) 2018, the 3b endoleak was relined with a non-endologix stent.There has been no patient sequelae reported at this time.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were reported evidence that supported the following case event.Clinical was able to confirm the following reported events: stent cage dilation main body 34%, type iiib endoleak main body, and a secondary endovascular procedure with non endologix stents done on (b)(6) 2018.In addition, on (b)(6) 2017, patient had a planned-stepped placement of a superior mesenteric artery (sma) chimney stent with an intraoperative type ia endoleak from a possible sma gutter leak, and a sac growth on the juxtarenal.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 stent (stretched 34% and breached) was the use of concomitant non endologix products.The proximal loss of seal was confirmed however it did not involve an endologix product.There were no procedure related harms identified.The final patient disposition has not been reported, there have been no further reports of negative patient sequelae.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

Endologix was made aware a patient with an endoleak type 3b within the main body and was also noted that the diameter of the graft have expanded to greater than 30mm based on review of patient's ct scan on a visit on (b)(6) 2018.The patient's initial procedure was performed on (b)(6) 2017 with an afx2, and in addition, an ovation iliac extension was placed inside the right limb of the afx2 stent graft and a vela infrarenal.On (b)(6) 2017, patient had another intervention done (a planned stepped procedure), in which a non-endologix (zfen) extension was "docked" into the afx to treat a juxta-renal aneurysm.With the type 3b identified on (b)(6) 2018, physician elected to do a re-intervention on (b)(6) 2018 and re-lined with another non-endologix stent to fix the problem.There has been no negative patient sequelae reported at this time.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7318101
• MDR Text Key: 101651449
• Report Number: 2031527-2018-00154
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014665
• UDI-Public: (01)00818009014665(17)180718
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

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: Physician
• Device Expiration Date: 07/18/2018
• Device Model Number: BEA25-120/I20-40
• Device Lot Number: 1722009005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 02/20/2018
• Supplement Dates FDA Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON-ENDOLOGIX GRAFT - LOT UNK; OVATION IX EXTENDER - LOT: FS092816-55; VELA INFRARENAL - LOT: 1588910010; NON-ENDOLOGIX GRAFT - LOT UNK; OVATION IX EXTENDER - LOT: FS092816-552; VELA INFRARENAL - LOT: 1588910010
• Patient Outcome(s): Other
• Patient Age: 71 YR