MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-100/I16-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	07/07/2020
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 afx with duraply.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm.Approximately four (4) years post initial implant during a routine follow up ct (computed tomography) identified sac growth of 6.6cm and a possible type 1b endoleak.Patient is reported as doing well and has a follow-up angiogram pending at a future undisclosed date.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.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/incident was completed.The type 1b endoleak event is unconfirmed due to a lack of relevant medical imaging.Device, user, procedure or anatomy relatedness of this event could not be determined.No procedure related harms were identified.During the investigation, endologix found reasonable evidence to suggest the device was used off-label due to non-endologix coils were placed to treat type 2 endoleaks (non-device related failures) of the lumbar and internal mesenteric arteries.This procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.These findings were discovered during an examination of the operative note dated (b)(6) 2017.The final patient status was reported as discharged on the first post operative day home stable following a secondary endovascular repair.No additional investigation of this reported adverse event/incident 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/incidents.Device iteration is afx with duraply.Corrections: b2: outcomes attributed to adverse events has been updated.H6: method code: remove code 4114.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm.Approximately four (4) years post initial implant during a routine follow up ct (computed tomography) identified sac growth of 6.6cm and a possible type 1b endoleak.Patient is reported as doing well and has a follow-up angiogram pending at a future undisclosed date.Additional information: the physician completed a successful reintervention and treated the patient with an ovation ix extender.The patient was reportedly in stable condition post procedure.In addition, during review of the operative note dated (b)(6) 2017 clinical review identified non-endologix coils were placed to treat type 2 endoleaks (non-device related failures) of the lumbar and internal mesenteric arteries.This procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10322329
• Report Number: 2031527-2020-00218
• Device Sequence Number: 17080967
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)171119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2017
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1252300006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 09/30/2020
• 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,LOT1252412002; AFX,VELA SUPRARENAL,LOT1252412002
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR