MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA25-110/I16-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Unspecified Infection (1930); Pain (1994); Rupture (2208)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional 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.Device iteration is afx2.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately three (3) months post initial procedure, the patient had surgery to remove the portion of the jejunum that was adhered to the distal aneurysm sac which eroded into the graft.A year later, the patient presented emergently with abdominal pain, a possible rupture, and an infection (active ecoli bactoremia).Cta (computed topography angiography) revealed aneurysm sac growth (unknown diameter) and a possible type iiib endoleak.The physician elected to treat the patient by implanting an additional bifurcated afx2 device on (b)(6) 2019.The aneurysm was successfully excluded but the patient continues to be in poor condition due to the infection.
Additional 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: the urgent presentation, rupture, an infection in the aorta, type iiib endoleak in the main body, and secondary endovascular procedure.There was unsubstantial evidence to support the reported event of sac growth due to the lack of comparative images.The event is most likely anatomy- and unintentional user-related; contributing factors for the rupture and sac growth was most likely the pre-existing aorta and mesenteric infection, and for the type iiib endoleak of the bifurcated device was most likely the extra manipulation during the surgery to remove the portion of the jejunum.The procedure-related harms for this event could not be determined.The final patient status was reported in poor condition due to infection and in hospice care.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.H6 result code - remove 3233.H6 conclusion code - remove 11.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8946117
• Report Number: 2031527-2019-00391
• Device Sequence Number: 2521482
• Product Code: MIH
• UDI-Device Identifier: 00818009014856
• UDI-Public: (01)00818009014856(17)180810
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 08/10/2018
• Device Model Number: BEA25-110/I16-30
• Device Lot Number: 1727729-009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL: 1753458-015; AFX VELA SUPRARENAL: 1753458-015
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR