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

Model Number	TV-IL1410160-J
Medical Device Problem Codes	Complete Blockage (1094); Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Obstruction/Occlusion (2422); Clinical Endoleak (4843)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) with the alto stent graft system.Approximately thirty-one (31) days post initial procedure at routine follow-up, it was identified that the left limb of the stent graft had migrated downwards in the patient's body.The patient is in stable condition.A re-intervention is planned to address the issue, but surgery has not 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.H3 other text : device remains implanted.
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) with the alto stent graft system.Approximately thirty-one (31) days post initial procedure at routine follow-up, it was identified that the left limb of the stent graft had migrated downwards in the patient's body.The patient is in stable condition.A re-intervention is planned to address the issue, but surgery has not been scheduled.Additional information: the initial report indicated a "limb went down - migration" scenario.However, upon a comprehensive review of the computerized tomography (ct) scan results, it became evident that the intended interpretation was that the "limb went down" in the context of occlusion, rather than signifying migration.The objective findings from the computerized tomography (ct) scan conducted on (b)(6), 2023, show the complete occlusion of the left limb.This conclusion aligns with the clinical summary, which also confirms the occlusion of the left limb.The identified contributing factors suggest that the occurrence of angulation upon ab's landing led to the occlusion of the left limb.The patient underwent a secondary procedure during which the physician chose to perform the implantation of vbx (non-endologix) stents utilizing the kissing stent technique.A clinical evaluation also shows reasonable evidence to suggest a type ii endoleak (non¿device related failure) also occurred.It was reported the patient was discharged following the secondary procedure.
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 ovation ix, left limb occlusion is confirmed.The additional endovascular procedure is also confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type ii endoleak (non¿device related failure) also occurred.The type ii endoleak was discovered on (b)(6), 2023, on the review of the computerized tomography (ct) scan dated (b)(6) 2023.The complaint is most likely anatomy-related.There was an infrarenal angle of 57.9 degrees.The unsupported fabric of the aortic body landed in this angulation causing the left limb to occlude (anatomy related).It is unclear if the b cell lymphoma contributed to a hypercoagulable state.Procedure-related harms of this complaint could not be determined with the medical records available for review.It was reported the patient was discharged following the secondary 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.Corrections: b5 describe event or problem g3 awareness date h6medical device problem codes; remove 3026 h6 investigation finding codes; remove 3233 h6 investigation conclusion codes; remove 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: 17144835
• Report Number: 3008011247-2023-00080
• Device Sequence Number: 5578015
• Product Code: MIH
• UDI-Device Identifier: 00850007370114
• UDI-Public: (01)00850007370114(17)250914(10)FS091422-31
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/25/2023

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: 09/14/2025
• Device Model Number: TV-IL1410160-J
• Device Catalogue Number: TV-IL1410160-J
• Device Lot Number: FS091422-31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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 FS101822-29; OVATION IX ILIAC LIMB FS010523-07; OVATION PRIME FILL POLYMER FF082922-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male