MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; SUPRARENAL AORTIC EXTENSION

Model Number	A34-34/C100-O20
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354); Unintended Movement (3026)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Exsanguination (1841); Failure of Implant (1924); Shock (2072); Rupture (2208)
Date of Event	05/06/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is not available for return.
Event or Problem Description
An afx abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Initial implant occurred 3 years ago.Patient returned emergently approximately one month ago with abdominal pain.A ct was done which showed a type 3a endoleak with complete component separation.The physician elected to implant two infrarenal aortic extensions and successfully resolved the endoleak.One day post-op the patient experienced a ruptured aneurysm due to an undetected type 1a endoleak and subsequently expired.
Additional Manufacturer Narrative
At the completion of the investigation based on available information clinical evaluation was able to find substantial evidence to support the following reported events; rupture, persistent endoleak, and secondary diagnostic angiogram.There was no evidence to support the reported death.Additionally there was evidence to reasonably support a diagnostic angiogram, no endovascular or surgical intervention for rupture, and hemodynamic instability.Clinical evaluation found evidence to refute the reported successful secondary repair, rather, there was evidence of a persistent endoleak which was a result of the aneurysm not excluded due to a type iiib endoleak of the cuff which lead to a type ia endoleak, due to a partial crown separation.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 loss of seal and compromised stent graft integrity of the cuff was the strata material.However, the persistent leak was unsuccessfully mitigated.This unintentional user error caused the rupture and death two days post the repair procedure.A moderately angled aortic neck, and a cautionary product use condition of calcifications at the aortic neck, likely contributed to this event.No procedure related complications or off-label conditions could be identified due to lack medical information surrounding this event.Associated clinical harms included: rupture, hemodynamic instability, type iiib endoleak, and type ia endoleak - cuff (persistent post repair), an additional secondary procedure (diagnostic angiogram), and death.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; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place (b)(6) 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 less than 0.2%.Device was not returned, therefore, sample evaluation was not completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.(b)(4).

• Brand Name: AFX
• Common Device Name: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6610340
• Report Number: 2031527-2017-00290
• Device Sequence Number: 739411
• Product Code: MIH
• UDI-Device Identifier: 00818009013545
• UDI-Public: (01)00818009013545(17)200322
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2017

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: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: A34-34/C100-O20
• Device Catalogue Number: A34-34/C80 V
• Device Lot Number: 1056060-018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/03/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Patient Weight: 70