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

Model Number	TV-IL1428120-J
Medical Device Problem Codes	Off-Label Use (1494); Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Pain (1994); Stenosis (2263)
Date of Event	09/14/2021
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 initially implanted with an alto main body and three (3) ovation ix iliac limb stent-grafts to treat an abdominal aortic aneurysm (aaa).Approximately fifteen (15) days post initial procedure the patient presented to the emergency room with vomiting and flank pain.The computed tomography (ct) scan showed limb migration as well as a type 1b endoleak.Re-intervention was completed with implant of an ovation ix iliac limb.The type 1b endoleak was successfully resolved.The final patient status was reported as recovering with no issues.
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 could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.During the investigation, endologix found reasonable evidence to suggest this case is off-label (neck angulations >60°), however unable to confirm if this could be the contributing factors.The final patient status was reported as recovering with no issues.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: g4: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with an alto main body and three (3) ovation ix iliac limb stent-grafts to treat an abdominal aortic aneurysm (aaa).Approximately fifteen (15) days post initial procedure the patient presented to the emergency room with vomiting and flank pain.The computed tomography (ct) scan showed limb migration as well as a type 1b endoleak.Re-intervention was completed with implant of an ovation ix iliac limb.The type 1b endoleak was successfully resolved.The final patient status was reported as recovering with no issues.Additional information: an internal clinical assessment determined that there was evidence to reasonably suggest sac growth of 16mm and aortic stenosis of 40-50% occurred.The aortic neck was off label (neck angulations >60°).The final patient status was reported to be doing fine.
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 that the type 1b endoleak of the left common iliac artery is confirmed.This is moderately 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 clinical evaluation also shows reasonable evidence to suggest sac growth of 16mm and aortic stenosis of 40-50% occurred.The investigation also found that the aortic neck was off label (neck angulations >60°); however, it was unclear if this contributed to the report event.The final patient status was reported to be doing fine.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 has been updated.B6: relevant tests and lab data has been updated.G3: date received by manufacturer has been 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: 12538247
• Report Number: 3008011247-2021-00117
• Device Sequence Number: 4112723
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428120J1
• UDI-Public: +M701TVIL1428120J1/$$3240301FS02262123D
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/14/2021

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: 03/01/2024
• Device Model Number: TV-IL1428120-J
• Device Catalogue Number: TV-IL1428120-J
• Device Lot Number: FS022621-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 12/23/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 11/08/2021; 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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 FS060821-59.; OVATION IX ILIAC LIMB FS060121-12.; OVATION IX ILIAC LIMB FS060221-10.; OVATION IX ILIAC LIMB FS062321-01.; OVATION PRIME FILL POLYMER FF052021-04.; ALTO MAIN BODY FS060821-59; OVATION IX ILIAC LIMB FS060121-12; OVATION IX ILIAC LIMB FS060221-10; OVATION IX ILIAC LIMB FS062321-01; OVATION PRIME FILL POLYMER FF052021-04
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female