MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; MAIN BODY

Model Number	TV-AB2980-J
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Rupture (2208); Clinical Endoleak (4843)
Date of Event	04/11/2024
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 treated for an abdominal aortic aneurysm (aaa) with the implant of the with the ovation ix stent graft system and an ovation ix extender on (b)(6) 2017.On (b)(6)2024, the patient presented emergently with abdominal pain and a contained rupture.Examination revealed both common iliac arteries were now aneurysmal.Both limbs moved proximally and were in the infrarenal sac.The physician elected to treat the patient by coiling both hypogastric arteries and implanting four (4) ovation ix iliac limbs.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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 that the ovation ix, aortic rupture, cranial implant movement, and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The infrarenal and iliac tortuosity could have contributed to the reported event, but that could not be conclusively determined.The clinical evaluation also shows reasonable evidence to suggest that a type ib endoleak of the right common iliac artery also occurred.The type ib endoleak was discovered during a review of the computed tomography (ct) scan dated april 10, 2024.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 remains unknown.The final patient status was not made available to endologix.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.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• 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: 19272163
• Report Number: 3008011247-2024-00051
• Device Sequence Number: 12636159
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3191003FS042616102
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/11/2024

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: 10/31/2019
• Device Model Number: TV-AB2980-J
• Device Lot Number: FS042616-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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: OVATION IX ILIAC LIMB FS042016-69; OVATION IX EXTENDER FS041916-44; OVATION IX ILIAC LIMB FS060316-03; OVATION PRIME FILL POLYMER FF032916-02
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown