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

Model Number	TV-IL1414140-J
Medical Device Problem Codes	Complete Blockage (1094); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/12/2021
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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the alto abdominal aortic aneurysm stent system.Approximately eight (8) days post initial procedure, the patient presented emergently with leg pain due to a kinked and occluded right iliac limb.The physician elected to treat the patient by cannulating the limb and re-inforcing with a gore(non-endologix) vbx stent graft on (b)(6) 2021.The patient is reportedly in good condition.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.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 right limb buckling and stenosis (near occlusion) and secondary endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest polymer ring invagination and two type ii endoleaks (lumbar) occurred.These findings were discovered during an examination of the post index ct scan.The most likely causation for the right limb buckling and stenosis is user related as the iliac limb placement was offset by 6-9mm proximally.Type ii endoleaks are anatomy-related events and are not caused or contributed by the device.The final patient status was discharged on the second post-operative day home stable.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.H6: device code: remove 1094.H6: result code: remove 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the alto abdominal aortic aneurysm stent system.Approximately eight (8) days post initial procedure, the patient presented emergently with leg pain due to a kinked and occluded right iliac limb.The physician elected to treat the patient by cannulating the limb and re-enforcing with a gore(non-endologix) vbx stent graft on (b)(6) 2021.The patient is reportedly in good condition.Subsequent to the initial report; clinical assessment determined that there was evidence to reasonably suggest polymer ring invagination and two type ii endoleaks (lumbar) occurred that was not included in the event as reported.These findings were discovered during a review of the post index ct scan dated.Additionally, clinical assessment confirmed stenosis, not occlusion (as reported).

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 12360075
• Report Number: 3008011247-2021-00098
• Device Sequence Number: 3891743
• Product Code: MIH
• UDI-Device Identifier: 00850007370220
• UDI-Public: (01)00850007370220(17)240526(10)FS05252129
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: 05/26/2024
• Device Model Number: TV-IL1414140-J
• Device Lot Number: FS052521-29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTO MAIN BODY, SN (B)(6) ; FILL POLYMER, SN (B)(6) ; OVATION IX ILIAC LIMB, SN (B)(6) ; ALTO MAIN BODY, SN (B)(4) ; FILL POLYMER, SN (B)(4) ; OVATION IX ILIAC LIMB, SN (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR