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

Model Number BA22-90/I16-30

Device Problems Looping (1370); Difficult To Position (1467); Premature Activation (1484); Difficult to Advance (2920)

Patient Problems Aneurysm (1708); Death (1802)

Event Date 10/18/2013

Event Type  Death  

Manufacturer Narrative

Endologix continues to investigate the reported event.Endologix will submit a supplemental report in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

It was reported that during implantation of a bifurcated device, the physician experienced difficulties with wire wrap resulting in deployment in an unintended location that required conversion to surgical procedure, and explant.During difficult advancement of the bifurcated device, it was observed under fluoroscopy that the guide wire was looped on itself at the level of the aortic bifurcation.The physician was able to un-wrap the guide wire by turning both, the introducer sheath and device main body, and continued device advancement.The distal contralateral limb marker was positioned above the aortic bifurcation and the introducer sheath was pulled back; however, this resulted in exposing the contralateral limb at the ipsilateral side.Several unsuccessful attempts to re-position the contralateral limb were performed, by turning the inner core; however, the contralateral limb would not turn.Angiography also revealed that the proximal end of the bifurcated device was opened.While the physician was unsuccessfully manipulating the inner core, the tip of the delivery system was inadvertently pulled back, and the ipsilateral limb deployed.The bifurcated device could not be further repositioned.The physician elected to complete device deployment.After deployment was completed, an angiogram revealed no filling of the renal arteries, and it was presumed that the bifurcated device may have covered them.The physician elected to explant the devices and convert to open repair.The procedure was concluded and the patient was transferred to the floor.The patient was extubated and reportedly recovered from the procedure, and was able to walk around the floor.It was indicated the patient suddenly died 6 days post-procedure.The implanting physician indicated the death was definitively related to the patient's advanced age.Additional information: very large aneurysm with challenging angulation and tortuosity in infrarenal neck.

• Brand Name: AFX SYSTEM
• Type of Device: INFRARENAL BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 11 studebaker; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 11 studebaker; irvine CA 92618
• Manufacturer Contact: brian hudson ; 11 studebaker; irvine, CA 92618 ; 9495957236
• MDR Report Key: 3588360
• MDR Text Key: 45501345
• Report Number: 2031527-2013-00291
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2013

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?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2016
• Device Model Number: BA22-90/I16-30
• Device Lot Number: 1052784-018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2013
• Initial Date FDA Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 94 YR
• Patient Sex: Female