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

Model Number	TV-IL1418160-J
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Stenosis (2263); Pseudoaneurysm (2605); Ruptured Aneurysm (4436); Clinical Endoleak (4843)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
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.Devices remain implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.Approximately three (3) months post initial procedure, the patient was readmitted on (b)(6) 2023 for coiling of the left internal iliac artery with left iliac stent placement due to a type ib endoleak, left iliac pseudoaneurysm, cranial migration and aneurysm enlargement.The patient was discharged for a brief period.No additional information is currently available regarding this initial report.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.Approximately three (3) months post initial procedure, the patient was readmitted on 17 february 2023 for coiling of the left internal iliac artery with left iliac stent placement due to a type ib endoleak, left iliac pseudoaneurysm, cranial migration and aneurysm enlargement.The patient was discharged for a brief period.No additional information is currently available regarding this initial report.Additional information: clinical assessment identified that a suspect, contained rupture in the patient's aorta was indicated per internal clinical documentation dated 16 february 2023.In addition, aortic stenosis was indicated per internal clinical documentation and ct (computed tomography) scans dated 19 december 2022 and 16 february 2023.
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.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 the reported ovation ix, type ib endoleak (of the left common iliac artery), left iliac pseudoaneurysm, cranial migration (of the left iliac neck), abdominal aneurysm enlargement (of 9.8 mm) and additional endovascular procedure (left internal iliac artery coil and left common iliac artery stent 02/17/20230) are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest aortic body stenosis.This finding was discovered during an examination of ct (computed tomography) scans dated 19 december 2022 and 16 february 2023.In addition, while a possible contained rupture in the left iliac is indicated per eclinical documentation dated 16 february 2023, the rupture could not be confirmed.No procedure-related harms were identified.Device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.It was also noted that the patient was admitted on 02 february 2023 with gas bacteremia and sepsis, which were most likely related to a skin and soft tissue infection of the left lower extremity.There was also a pericolonic abscess, a potential source of the sepsis.It is likely the graft became infected due to either the left lower extremity infection or pericolonic abscess.Lastly, the bactermia, endocarditis and acute renal failure were deemed not device-related per eclinical documentation.The final patient status was reported as discharged in improved and stable condition on the seventh post operative day.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: b2 date of event.B5 describe event or problem.G3 awareness date.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: 17311557
• Report Number: 3008011247-2023-00143
• Device Sequence Number: 7157894
• Product Code: MIH
• UDI-Device Identifier: 00850007370374
• UDI-Public: (01)00850007370374(17)250706(10)FS070522-31
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: 07/06/2025
• Device Model Number: TV-IL1418160-J
• Device Catalogue Number: TV-IL1418160-J
• Device Lot Number: FS070522-31
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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, LN FS092322-28; OVATION IX ILIAC LIMB, LN FS061622-17; OVATION PRIME FILL POLYMER, LN FF032822-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male