MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-70/I16-30
Medical Device Problem Codes	Off-Label Use (1494); Appropriate Device Problem Term/Code Not Available (3191); Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Unspecified Infection (1930); Renal Failure (2041)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of an afx bifurcated stent graft and an afx vela suprarenal.Approximately seven (7) years post initial procedure at routine follow-up, the computerized tomography scan identified a type iiia endoleak of the bifurcated stent graft and a type ia of the vela suprarenal.Reintervention has not yet been planned.The patient is doing well.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.
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.Endologix received a one (1) afx bifurcated stent graft and one (1) afx vela suprarenal stent graft for evaluation.The devices were shipped in a separate biohazard returned bag within a one (1) box.Blood and tissue residue were present upon receipt.The devices were decontaminated.A visual analysis was performed.The afx bifurcated stent graft was received damaged.One of the limbs was completely cut off.The afx vela suprarenal stent graft was also received damaged.A large hole was present in the middle of the graft and the stent was deformed in the same area.The damage to both devices most likely occurred when being explanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type 3a endoleak of the aortic components with complete separation and graft explant was confirmed.The type 1a endoleak could not be confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest sac growth of 13.5mm and migration also occurred.The sac growth and migration were discovered during the review of the computed tomography (ct) scan.Procedure-related harms for this complaint are hypotension, abnormal blood loss, cerebral vascular accident, sepsis, and acute kidney injury on chronic kidney disease.The final patient status was reported as being discharged home from rehabilitation.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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of an afx bifurcated stent graft and an afx vela suprarenal.Approximately seven (7) years post initial procedure at routine follow-up, the computerized tomography scan identified a type iiia endoleak of the bifurcated stent graft and a type ia of the vela suprarenal.Reintervention has not yet been planned.The patient is doing well.Additional information: an open repair with the explant of the devices was completed on 11apr2022.The patient was reported as doing well.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 13978304
• Report Number: 2031527-2022-00073
• Device Sequence Number: 20341309
• Product Code: MIH
• UDI-Device Identifier: 00818009010117
• UDI-Public: (01)00818009010117(17)171027
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 10/27/2017
• Device Model Number: BA28-70/I16-30
• Device Lot Number: 1265923024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 (LN 1259053010)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female