MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-70/I20-30
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Failure of Implant (1924); Pain (1994); Shock (2072)
Date of Event	07/29/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
To date the incident devices have not been received for evaluation.If the devices are received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent, a suprarenal aortic extension and two limb extensions.On (b)(6) 2016 the patient had a secondary procedure to repair a type 3a endoleak with component separation of both iliac limbs.The physician implanted two additional limb extensions to resolve the endoleak.At the completion of the investigation the event was confirmed in addition a type 2 endoleak was observed at the end of the secondary procedure.On (b)(6) 2017 it was reported the patient came in emergently and before the patient was able to receive a computed tomography (ct) scan the patient expired.The physician is suspecting a possible type 3b endoleak.
Additional Manufacturer Narrative
Based on the information received, clinical evaluation confirmed the reported type iiib endoleak of the main body; shock; urgent presentation; death.Additional findings based on clinical evaluation were stent cage dilation of the cuff (26%), rupture and retroperitoneal bleed.The most likely cause of the compromised stent graft integrity of the main body (breach) was the severe lateral movement and compromised stent graft integrity (stretched) of the cuff.A year prior to this event limbs stents were added to the main body due to a distal endoleak caused by an off label iliac anatomy; this repair procedure might have change the integrity of the main body stent (cautionary product use condition).The most likely cause of the compromised stent graft integrity of the cuff (stretched) was the off label and cautionary neck anatomy (intentional user error) and the eventual lateral movement.There was no procedure-related harms detected.The patient expired in the emergency room before an attempt to surgically repair the rupture and retroperitoneal bleed.The manufacturing records confirm that all lots met all requirements prior to release.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.The type iiib endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at 2.5%.Since the corrective actions were implemented, the type iiib endoleak events reported for afx devices has been reduced to <0.2%.The devices remain implanted in the patient and will not be returned for device evaluation.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6831839
• Report Number: 2031527-2017-00434
• Device Sequence Number: 1407980
• Product Code: MIH
• UDI-Device Identifier: 00818009012623
• UDI-Public: (01)00818009012623(17)180420
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2018
• Device Model Number: BA28-70/I20-30
• Device Lot Number: 1331248-012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIMB STENT GRAFT- 1252603-025; LIMB STENT GRAFT- 1252613-028; LIMB STENT GRAFT- 1253174-015; LIMB STENT GRAFT- 1317721-011; VELA SUPRARENAL- 1333213-001
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR