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

Model Number	TV-IL1414100-J
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with afx2 bifurcated stent graft, an afx vela suprarenal, and an ovation ix iliac limb.This case is outside the indications of use (off -label) due the use of afx with ovation devices.Approximately one (1) month post initial procedure a type ii endoleak and a type ib endoleak were identified with no aneurysm enlargement.The physician elected to monitor the patient.(reported under mfr# 3008011247-2018-00066).Now, approximately four (4) years post initial procedure the type ii endoleak and a type ib endoleak are persistent.Reintervention has been scheduled.
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.
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.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 type ib endoleak from the right common iliac artery, type ii endoleak from the internal mesenteric artery and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation shows that the type ii endoleak is anatomy related.Procedure related harms, device, user, procedure or anatomy relatedness of the type ib endoleak complaint could not be determined.The final patient status was reported as being discharged on the first post operative day home 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: b5: describe event or problem - updated.G3: date received by manufacturer - updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with afx2 bifurcated stent graft, an afx vela suprarenal, and an ovation ix iliac limb.This case is outside the indications of use (off -label) due the use of afx with ovation devices.Approximately one (1) month post initial procedure a type ii endoleak and a type ib endoleak were identified with no aneurysm enlargement.The physician elected to monitor the patient.(reported under mfr# 3008011247-2018-00066).Now, approximately four (4) years post initial procedure the type ii endoleak and a type ib endoleak are persistent.Reintervention has been scheduled.Additional information: patient re-intervention was completed.Physician elected to implant an ovation ix extender to resolve the 1b endoleak.

• 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: 13537757
• Report Number: 3008011247-2022-00011
• Device Sequence Number: 20112519
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414100J1
• UDI-Public: +M701TVIL1414100J1/$$3201004FS09081758N
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 02/08/2022

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: 10/04/2020
• Device Model Number: TV-IL1414100-J
• Device Catalogue Number: TV-IL1414100-J
• Device Lot Number: FS090817-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2017
• 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 VELA SUPRARENAL (LN 1751547001).; AFX2 BIFURCATED STENT GRAFT (LN 1722336005).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male