MAUDE Adverse Event Report: GRACE HOSPITAL AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA25-120/I20-40
Medical Device Problem Codes	Partial Blockage (1065); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	08/14/2020
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 afx2.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, an afx suprarenal stent graft extension, an afx infrarenal stent graft extension and a ovation ix extender to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off -label) due the use of afx with ovation devices.Approximately 45 days post-operation, the patient presented with lower leg numbness, during the ct (computed tomography) scan the physician observed a clot formation in the mid aortic portion of the bifurcated stent graft.The physician elected to implanted two ovation lilac limbs to resolve this event.The patient was reported as stable.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, an afx suprarenal stent graft extension, an afx infrarenal stent graft extension and a ovation ix extender to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off -label) due the use of afx with ovation devices.Approximately 45 days post-operation, the patient presented with lower leg numbness, during the ct (computed tomography) scan the physician observed a clot formation in the mid aortic portion of the bifurcated stent graft.The physician elected to implanted two ovation lilac limbs to resolve this event.The patient was reported as stable.Additional information: the clinical assessment identified buckling of the bifurcated stent graft and sac growth of 11.5 mm.
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/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the reported obstruction was identified as bifurcated stent graft buckling causing an aortic occlusion and the secondary endovascular procedure were confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest buckling of the main body and sac growth of 11.5mm.The most likely causation for these events are user related due to the off label (use of adjunctive devices not compatible with afx system per the ifu) use of the ovation limb in the afx2 bifurcated stent graft causing the stent graft to buckle then causing the obstruction.The final patient status was discharged on the first post operative day following a secondary endovascular procedure.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 afx2.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): GRACE HOSPITAL; 2201 s sterling st; morganton NC 28655
• MDR Report Key: 10504535
• Report Number: 2031527-2020-00249
• Device Sequence Number: 3055649
• Product Code: MIH
• UDI-Device Identifier: 00818009014665
• UDI-Public: (01)00818009014665(17)181127
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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: 11/27/2020
• Device Model Number: BEA25-120/I20-40
• Device Lot Number: 1762287006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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 INFRARENAL - 2352563009; AFX VELA SUPRARENAL - 2330460003; AFX VELA INFRARENAL - 2352563009; AFX VELA SUPRARENAL - 2330460003
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR