MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-120/I20-40

Device Problems Material Puncture/Hole (1504); Product Quality Problem (1506); Stretched (1601); Use of Device Problem (1670); Material Integrity Problem (2978)

Patient Problems Aneurysm (1708); Death (1802); Failure of Implant (1924); Rupture (2208)

Event Date 02/09/2019

Event Type  Death  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately 5.5 years post initial procedure, the patient presented emergently with a rupture and type iiib endoleak of the bifurcated stent graft (main body).The physician elected to treat the patient by implanting an infrarenal and suprarenal stent graft aortic extensions on (b)(6) 2019; however, the type iiib endoleak was not resolved and the patient expired post-op.

Event Description

Additional information received per clinical assessment confirming that the initial implant was completed with concomitant devices and the patient's anatomy included an off-label neck (both off-label use).The following were also found to have occurred at the time of the reported event: a type ia endoleak and stent cage dilation (27%) of the proximal extension with aneurysm enlargement (17mm).

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: type iiib endoleak of the bifurcated device, rupture, unsuccessful secondary endovascular procedure with placement of two (2) proximal extension grafts, and subsequent patient death.The event is most likely device-related due to the use of strata material.In addition, the clinical assessment determined there was evidence to reasonably suggest that the following occurred, which were not included in the event as reported: type ia endoleak, stent cage dilation of the proximal extension (27% stretched and breached), aneurysm sac growth by 17mm, and implantation of a non-endologix right side renal snorkel at the index procedure.These additional observations were discovered during review of the implant angiogram and the 67-month ct scan.The type ia endoleak was identified as related to the patient's off-label neck (4mm neck length, ifu states >15mm) as well as use of a non-endologix snorkel at initial implant (off-label use).Also, the rupture appeared to be a result of the distal type iiib endoleak, which was related to the strata material.The procedure-related harms for this complaint could not be determined.The manufacturing lot review 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.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 july 2014.Conclusion code: remove 11.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8400971
• MDR Text Key: 138142870
• Report Number: 2031527-2019-00113
• Device Sequence Number: 1
• Product Code: MIH
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: BA25-120/I20-40
• Device Lot Number: 1111624-010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX-LIMB STENT GRAFT: 1039941-001; AFX-LIMB STENT GRAFT: 1039962-007; AFX-SUPRARENAL AORTIC EXTENSION: 1047255-014; AFX-LIMB STENT GRAFT: 1039941-001; AFX-LIMB STENT GRAFT: 1039962-007; AFX-SUPRARENAL AORTIC EXTENSION: 1047255-014
• Patient Outcome(s): Death
• Patient Age: 61 YR