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

Model Number	BEA25-80/I13-40
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	12/14/2018
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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 bifurcated stent graft and ovation ix iliac limb.Approximately eight (8) months post initial procedure, the patient presented with a proximal leak in the bifurcated device (type ia endoleak).The physician elected to treat the patient by implanting an infrarenal afx device on (b)(6) 2019.There have been no additional patient sequelae reported.
Event or Problem Description
Additional information received per clinical assessment refuting the reported type ia endoleak and confirming that rather a type ii endoleak was present at the time of the reported event.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following observation: the type ia endoleak complaint is refuted and rather, there is a type ii endoleak from the inferior mesenteric artery.The complaint is most likely anatomy-related.Procedure-related harms for this complaint could not be determined, and the final patient status was not reported.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.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8351580
• Report Number: 2031527-2019-00095
• Device Sequence Number: 13900403
• Product Code: MIH
• UDI-Device Identifier: 00818009014788
• UDI-Public: (01)00818009014788(17)180718
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2018
• Device Model Number: BEA25-80/I13-40
• Device Lot Number: 1722007-007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/16/2019
• 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: OVATION IX-ILIAC LIMB:(B)(4); OVATION IX-ILIAC LIMB:FS071117-71
• Outcome Attributed to Adverse Event: Required Intervention