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

Model Number BEA25-100/I16-40

Device Problems Collapse (1099); Leak/Splash (1354); Off-Label Use (1494)

Patient Problem Failure of Implant (1924)

Event Date 03/06/2018

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 information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

On (b)(6) 2018, endologix was made aware from a rep regarding a patient with a possible type 3 endoleak between afx main body and aortic extension from a post op 1 month follow up ct.In addition, patient was also noted for a possible type ia endoleak in the anterior portion of the aorta in which it appeared that there was no adhesion of the cuff to the vessel wall; and a possible collapse of the proximal portion of the aortic extension towards the posterior aorta.Images were attached for further evaluation with the third image as most impressive, where they can see that the cuff is almost closed in the proximal edge.There was no scheduled re-intervention confirmed or how this patient will be treated going forward.No additional information provided.

Manufacturer Narrative

Based on the clinical assessment performed the reported type iiia endoleak complaint is refuted rather there is type ia endoleak.The infra renal superior stent margin cuff collapse complaint is confirmed.The root cause is most likely user related (off-label neck angulation).The procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was not reported.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.

Event Description

Subsequent to the previously submitted report, additional information was received reporting that there a secondary treatment was performed; however, detailed information is unknown.No additional information is available.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7429257
• MDR Text Key: 105417735
• Report Number: 2031527-2018-00325
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014726
• UDI-Public: (01)00818009014726(17)180905
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

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: 09/05/2018
• Device Model Number: BEA25-100/I16-40
• Device Catalogue Number: F00820-34
• Device Lot Number: 1736407013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 08/09/2018
• Supplement Dates FDA Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VELA INFRARENAL, LOT 1625010022; VELA INFRARENAL, LOT 1625010022
• Patient Outcome(s): Required Intervention