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

Model Number	TV-IL1410100-J
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2020, with the implant of an alto abdominal stent graft system.It was reported on february 20, 2024, that during a routine follow-up, a type ib endoleak of the right common iliac limb was identified.The patient's status is currently good pending a re-intervention.
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.H3 other text : device remains implanted.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2020, with the implant of an alto abdominal stent graft system.It was reported on february 20, 2024, that during a routine follow-up, a type ib endoleak of the right common iliac limb was identified.The patient's status is currently good pending a re-intervention.Additional information: the patient underwent a re-intervention procedure involving the implantation of a gore vbx stent graft (non-endologix).The precise date of this reintervention remains unknown.The final patient status was reported as doing well.
Additional Manufacturer Narrative
Available patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.An additional follow-up will be submitted upon completion of clinical evaluation.Corrections: b2: outcomes attributed to adverse events has been updated b5: describe event or problem ¿ updated.G3: awareness date ¿ updated.H6: health effect - impact code - remove 4614.
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 confirms the ovation ix type ib endoleak of the right common iliac artery complaint, along with the additional endovascular procedure (diagnostic angiogram).The additional endovascular procedure (non-elgx stent right common iliac artery) complaints are also confirmed.This is consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The final patient status was reported to be doing well.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: awareness date ¿ updated.B6: relevant test/lab data ¿ updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.H10/h11: additional manufacturer narrative/corrected data - updated.

• 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: 18952428
• Report Number: 3008011247-2024-00023
• Device Sequence Number: 7085117
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1410100J1
• UDI-Public: +M701TVIL1410100J1/$$3230616FS06152029H
• 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: 2020
• 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,Followup
• Report Date (Section B): 02/20/2024

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: 06/16/2023
• Device Model Number: TV-IL1410100-J
• Device Lot Number: FS061520-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 06/27/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/15/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• 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: ALTO MAIN BODY FS071620-05.; OVATION IX ILIAC LIMB FS052920-37.; OVATION PRIME FILL POLYMER FF042120-01.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female