MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number	TV-IL1418100-J
Medical Device Problem Codes	Off-Label Use (1494); Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	04/21/2022
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.
Event or Problem Description
The patient was implanted with the afx2 bifurcated stent graft and ovation ix iliac limb, afx limb stent graft, and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.Approximately (3) three years after post initial procedure, the patient was identified with sac growth in right common iliac (rcia) and a 3a endoleak with separation between the ovation ix iliac limb and the afx2 bifurcated stent graft.A re-intervention was completed.The physician implanted (2) two afx limb stent grafts to resolved the endoleak.The final patient status was reported to be doing well post re-intervention.
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.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 the type 3a endoleak (with component separation) of the aortic body and right iliac limb and the additional endovascular procedure was confirmed.The sac growth was unconfirmed.This is moderately consistent with the reported adverse event/incident.The most likely causation for the type 3a endoleak of the right iliac stent is user related; the initial implant procedure was outside the indications of use (off-label) due to a concomitant product (an ovation ix iliac limb) used with an afx bifurcated stent graft, and this likely contributed to the event that occurred.Procedure-related harms of this event could not be determined with the medical records available for review.The final patient status was reported as being in stable condition.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.Corrections: g3: date of received by manufacturer.H6: investigation finding codes - remove code 3233; h6: investigation conclusion codes - remove code 11.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• Manufacturer (Section G): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; ,; santa rosa CA 95403
• Manufacturer Contact: gary kirchgater ; 3910 brickway blvd; ,; santa rosa, CA 95403 ; 8009832284
• MDR Report Key: 14349995
• Report Number: 3008011247-2022-00044
• Device Sequence Number: 4907521
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418100J1
• UDI-Public: +M701TVIL1418100J1/$$3210328FS03061838R
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 03/28/2021
• Device Model Number: TV-IL1418100-J
• Device Catalogue Number: TV-IL1418100-J
• Device Lot Number: FS030618-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX LIMB STENT GRAFT 1927967-001; AFX VELA SUPRARENAL 1783139-010; AFX2 BIFURCATED STENT GRAFT 1732114-007
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male