MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I13-40
Medical Device Problem Codes	Misconnection (1399); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Rupture (2208); Stenosis (2263)
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.Approximately 4.5 years post initial procedure, the patient presented emergently with abdominal pain.Ct scan revealed a type iiia endoleak with component separation between the bifurcated and proximal extension devices.However, the exact date of event is not confirmed.The physician elected to treat the patient by implanting two (2) additional suprarenal afx devices on (b)(6) 2019, and the endoleak was confirmed successfully repaired at the conclusion of the procedure.The patient did well during the procedure and was reportedly stable.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported type iiia endoleak of the aortic components with complete component separation; it was confirmed that there was adequate overlap at the time of the initial implant and no endoleak.There was also evidence to reasonably suggest an aortic rupture, stenosis, and distal buckling of the bifurcated device occurred that was not included in the event as reported.The event is most likely anatomy-related due to the increase in the infrarenal angulation from 40° to 91° (aortic remodeling).Procedure-related harms for this event could not be determined.The final patient status was stable post secondary endovascular procedure.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.
Event or Problem Description
Additional information received per clinical assessment confirming that an aortic rupture with stenosis and buckling of the bifurcated device were also present.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8668420
• Report Number: 2031527-2019-00263
• Device Sequence Number: 2308719
• Product Code: MIH
• UDI-Device Identifier: 00818009010179
• UDI-Public: (01)00818009010179(17)171119
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2019

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: 11/19/2017
• Device Model Number: BA25-80/I13-40
• Device Lot Number: 1267157-010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2019
• Supplement Date Received by Manufacturer: 05/19/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-VELA SUPRARENAL:1252397-010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR