MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-110/I16-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.Device remains implanted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, an infrarenal stent graft extension and a limb stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 10 months post initial procedure, (exact date was not provided) a type 3b endoleak was reported.No further information was provided.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot review confirmed all devices met specifications prior to release.The devices were not returned as they remain implanted, and therefore no sample evaluation was completed.A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging; several requests were made and no response was received.As such, the event determination, off-label conditions, related patient harms, and patient disposition could not be assessed with medical records/ images.The final patient status was not reported.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx2.Corrections to h6: h6 result code; remove 3233 h6 conclusion code; remove 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9560846
• Report Number: 2031527-2020-00005
• Device Sequence Number: 14097857
• Product Code: MIH
• UDI-Device Identifier: 00818009014856
• UDI-Public: (01)00818009014856(17)190411
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 04/11/2019
• Device Model Number: BEA25-110/I16-30
• Device Lot Number: 1925857-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 08/14/2020
• 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: LIMB STENT GRAFT, LOT 2000504003; VELA INFRARENAL, LOT 1950542005
• Outcome Attributed to Adverse Event: Other