MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA22-60/I16-40

Device Problems Collapse (1099); Occlusion Within Device (1423); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Embolism (1829); Failure of Implant (1924); Occlusion (1984); Thrombus (2101)

Event Date 08/16/2017

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

Patient was initially implanted with a bifurcated stent to treat occlusive disease and an aortoiliac dissection.The procedure was completed and two hours post implant the patient experienced back pain, loss of bilateral distal pulse and coldness of the feet.The physician completed an angiogram and found an occlusion in the aorta.The physician inserted a catheter to begin tissue plasminogen activator (tpa) therapy before transferring the patient to (b)(6) hospital.Once transferred it was reported the patient had a clot in the left limb, an emboli in the left tibial peroneal trunk and an emboli in the left profunda.The physician completed several treatments including; an open thrombectomy, an injection of tpa, and heparinized saline with nitroglycerin.The physician ballooned the main body and both limbs.A final aortogram showed stent graft patency and no residual clot.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the information received, clinical evaluation confirmed the reported aortoiliac occlusive disease, dissection prior to implant, loss of distal pulses, total occlusion of the infra-renal aorta to iliacs (stent and vessel), distal emboli at initial endovascular and subsequent surgical procedure, and successful resolution of aortic and iliac occlusions.Additional clinical findings were that the stent had collapsed.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 inadequate stent graft patency was related to the off-label product use condition due to preexisting aortoiliac occlusive disease and symptomatic aortic dissection (cautionary product use condition).Additionally, there was evidence of a recurrent distal aortic stenosis at the area of the preexisting dissection (anatomy related).It was unclear whether this distal stenosis was resolved at the initial implant repair.The stent cage collapse was not observed on the repair angiogram.There were no procedure- related harms detected.Associated clinical harms for this device failure included: total infrarenal aortic iliac occlusion; secondary endovascular procedure, secondary surgical procedure, left lower extremity emboli.The patient was discharged home on the third post-operative day on anti-coagulation therapy.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.(b)(4).

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6868619
• MDR Text Key: 86300871
• Report Number: 2031527-2017-00463
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009015013
• UDI-Public: (01)00818009015013(17)171222
• 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: 08/16/2017

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: Health Professional
• Device Expiration Date: 12/22/2017
• Device Model Number: BEA22-60/I16-40
• Device Lot Number: 1632449-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR