MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Codes	Partial Blockage (1065); Occlusion Within Device (1423); Off-Label Use (1494)
Health Effect - Clinical Codes	Death (1802); Failure of Implant (1924); Ischemia (1942); Occlusion (1984); Reocclusion (1985); Renal Failure (2041); Respiratory Failure (2484)
Date of Event	05/26/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An afx2 bifurcated stent graft was implanted to treat an aiod occlusive aorta.The date of the index procedure, it was noted that the stent graft was thrombosed.A re-intervention to de-clot the graft was completed, however the patient was noted as not well after the re-intervention and remained on a ventilator.1 day post-op, the stent graft thrombosed again, and a second re-intervention to de-clot the graft was completed.The patient remained on a ventilator after the second re-intervention.Approximately 1 week post-op, a re-intervention was completed and a portion of the colon was removed and a colostomy was performed.The patient remains on ventilator and dialysis.As of the date of this report there have been no additional patient sequelae and will continue to be monitored.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, the clinical assessment was able to confirm an occlusion.The most likely cause of the occlusion within the device/inadequate stent graft patency was intentional user error; this device was used to treat aorto-iliac occlusive disease.The aorta, iliac and access vessel anatomies were off-label (intentional user error).Contributing factors included calcification and thrombus within the iliac arteries, a cautionary product use condition.Associated clinical harms for this device failure included: occlusion of the aorta, iliacs (vessels and stent) as well as other pelvic and lower limb vessels.Procedure-related harms that followed included: re-occlusion of the aorta/iliac arteries that required medical, endovascular and surgical intervention; eventual renal and respiratory failure that required mechanical ventilation and dialysis; mesenteric ischemia; and, death due to an ischemic bowel.The review of the manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.
Event or Problem Description
Additional information reported.The patient passed away on (b)(6) 2017 due to ischemic bowel.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6667914
• Report Number: 2031527-2017-00332
• Device Sequence Number: 19325592
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)180214
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2018
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 1654836002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 12/14/2017
• 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; Required Intervention
• Patient Age: 69 YR