MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-120/I16-40
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 in patient.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, and 2 (two) vela suprarenal stent graft extensions to treat an abdominal aortic aneurysm (aaa).Approximately 1 (one) year post initial procedure the patient was treated with implant of an additional afx vela suprarenal stent graft extension for a type ia endoleak, aneurysm enlargement, rupture, and migration with off label use (previously reported under mfr# 2031527-2019-00601).Approximately 6 (six) months post intervention a type ia endoleak with rupture was identified.Re-intervention completed by extending the seal zone by chimney of the superior mesenteric artery with 4 (four) afx vela suprarenal achieving seal.The patient was sent to the icu for monitoring due to the ruptured aneurysm.No additional information has been reported.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event was completed.An examination of medical records and/or medical imaging received by endologix shows the rupture, type 1a endoleak and secondary endovascular procedure events are confirmed.The most likely causation for the type 1a endoleak is the off-label neck anatomy and cautionary product use.The rupture and secondary endovascular procedure are related to the type 1a endoleak.The final patient status was reported being stable and transferred to rehabilitation center.No additional investigation of this reported adverse event is planned however, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events.Device iteration is afx2.H6: device code: remove code 3190 h6: result code: remove code 3233 h6: conclusion code: remove code 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10268754
• Report Number: 2031527-2020-00193
• Device Sequence Number: 10963409
• Product Code: MIH
• UDI-Device Identifier: 00818009014443
• UDI-Public: (01)00818009014443(17)181214
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 12/14/2018
• Device Model Number: BEA28-120/I16-40
• Device Lot Number: 1767421010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 09/04/2020
• 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: AFX VELA SUPRARENAL (LN 1727242012); AFX VELA SUPRARENAL (LN 1933825005); AFX VELA SUPRARENAL (LN 2270987001)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR