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

Model Number	TV-IL1416120-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Failure of Implant (1924); Rupture (2208)
Date of Event	12/13/2020
Type of Reportable Event	Death
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 ovation ix stent graft system and two extenders to treat an abdominal aortic aneurysm (aaa).Approximately one (1) year post initial procedure the patient presented symptomatic to the emergency room and with what appears to be a junction leak (classified as a type iiia endoleak) from the 16x120 and 16x45 limbs on the patient's right side.The physician repaired the endoleak with another manufacturer's stent grafts on (b)(6) 2020 and the endoleak was resolved.The patient was reported as doing fine post 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.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 type iiia endoleak (iliac component) complaint is unconfirmed.This is not consistent with the reported adverse event/incident.Procedure related harms identified were respiratory failure, hemodynamic instability, acute kidney failure and patient expired on (b)(6) 2020 @ 1726 post re-intervention.The clinical evaluation also shows reasonable evidence to suggest patient presented with an aortic rupture and post re-intervention, the patient expired on (b)(6) 2020.The most likely causation for the type 3a endoleak could not be determined due to a lack of relevant imaging.The rupture is most likely related to the type 3a endoleak.The death is related to the post operative complications following the secondary endovascular procedure.The patient had pre-existing respiratory disease, it is likely this contributed to the reported respiratory failure.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.
Event or Problem Description
The patient was initially implanted with an ovation ix stent graft system and two extenders to treat an abdominal aortic aneurysm (aaa).Approximately one (1) year post initial the patient was initially implanted with an ovation ix stent graft system and two extenders to treat an abdominal aortic aneurysm (aaa).Approximately one (1) year post initial procedure the patient presented symptomatic to the emergency room and with what appears to be a junction leak (classified as a type iiia endoleak) from the 16x120 and 16x45 limbs on the patient's right side.The physician repaired the endoleak with another manufacturer's stent grafts on (b)(6) 2020 and the endoleak was resolved.The patient was reported as doing fine post secondary procedure.Additional information: during the clinical assessment, an aortic rupture and the patient had expired on (b)(6) 2020 @ 1726 post re-intervention had been identified.These events were not included in the event 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: 11139564
• Report Number: 3008011247-2021-00002
• Device Sequence Number: 16731828
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416120J1
• UDI-Public: +M701TVIL1416120J1/$$3211017FS101018027
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: 10/17/2021
• Device Model Number: TV-IL1416120-J
• Device Catalogue Number: TV-IL1416120-J
• Device Lot Number: FS101018-02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 03/03/2021
• 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: OVATION IX EXTENDER, LOT # FS012219-47; OVATION IX EXTENDER, LOT # FS020118-16; OVATION IX FILL POLYMER, LOT # FF041019-01; OVATION IX ILIAC LIMB, LOT # FS020519-45; OVATION IX MAIN BODY, LOT # FS071119-33; OVATION IX EXTENDER, LOT # FS012219-47; OVATION IX EXTENDER, LOT # FS020118-16; OVATION IX FILL POLYMER, LOT # FF041019-01; OVATION IX ILIAC LIMB, LOT # FS020519-45; OVATION IX MAIN BODY, LOT # FS071119-33
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 86 YR