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

Model Number TV-IL1422120-J

Device Problems Deformation Due to Compressive Stress (2889); Unintended Movement (3026)

Event Date 04/24/2023

Event Type  Injury  

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.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.Approximately one (1) month post initial procedure, the patient presented with a proximal right iliac stent compression (greater than 50 percent), bilateral type ib endoleaks and outflow to the lumbar arteries (classified as a non-device-related type ii endoleak).The patient will continue to be monitored.

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, right iliac stent compression, non-device-related type ii endoleak (of the lumbar arteries, and type ib endoleak (of the right and left distal limbs) are confirmed.This is consistent with the reported adverse event/incident.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.The final patient status was reported as discharged home on postoperative day three.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.H6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 11.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.Approximately one (1) month post initial procedure, the patient presented with a proximal right iliac stent compression (greater than 50 percent), bilateral type ib endoleaks and outflow to the lumbar arteries (classified as a non-device-related type ii endoleak).The patient will continue to be monitored.Additional information: both limbs are pulled up proximally beyond the margins of the very short common iliacs resulting in the bilateral type 1b endoleaks.The physician elected to re-intervene and extended bilaterally with ovation ix iliac limbs on (b)(6) 2023 to resolve this event.

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, right iliac stent compression, non-device-related type ii endoleak (of the lumbar arteries, type ib endoleak (of the right and left distal limbs) and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.Additionally, both limbs are pulled up proximally beyond the margins of the very short common iliacs resulting in the bilateral type 1b endoleaks.The physician elected to re-intervene and extended bilaterally with ovation ix iliac limbs on 09/13/2023 to resolve this event.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.The final patient status was reported as discharged home on postoperative day three.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.

• Brand Name: OVATION IX
• Type of Device: 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: 16996793
• MDR Text Key: 315910066
• Report Number: 3008011247-2023-00067
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370336
• UDI-Public: (01)00850007370336(17)250812(10)FS081122-65
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TV-IL1422120-J
• Device Catalogue Number: TV-IL1422120-J
• Device Lot Number: FS081122-65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTO MAIN BODY, LN FS010423-01.; OVATION IX ILIAC LIMB, LN FS083022-53.; OVATION PRIME FILL POLYMER, LN FF070722-01.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR