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

Model Number	A28-28/C75-O20
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/26/2016
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 afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.During the initial procedure, an intraoperative type ia endoleak was detected due to inadequate overlap of the proximal extension and bifurcated device.The physician elected to implant an additional proximal extension just distal of the renal arteries, which resolved the endoleak.Approximately three (3) years post initial procedure, the patient presented with a stent graft junction (type iiia endoleak) between the bifurcated device and first implanted proximal extension.The physician elected to treat the patient by implanting a suprarenal afx device, a bare-metal (non-endologix) stent, and a palmaz (non-endologix) lg stent on (b)(6) 2019.The final angiogram confirmed that the junction leak was resolved.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Due to hospital strict policy, no data is available for this case.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.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.Correction: g1-2 contact office, g4, h6; h6 result code ¿ remove 3233.H6 conclusion code ¿ remove 11 and 22.

• Brand Name: AFX
• Common Device Name: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8928623
• Report Number: 2031527-2019-00383
• Device Sequence Number: 11294677
• Product Code: MIH
• UDI-Device Identifier: 00818009010360
• UDI-Public: (01)00818009010360(17)180923
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: 09/23/2018
• Device Model Number: A28-28/C75-O20
• Device Lot Number: 1343287-038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 03/03/2020
• 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-0008-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX BIFURCATED STENT GRAFT: 1328237-007; AFX SUPRARENAL AORTIC EXTENSION: 1343287-054
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR