MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR) OVATION IX; ILIAC LIMB

Model Number	TV-IL1428120-J
Medical Device Problem Codes	Complete Blockage (1094); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Occlusion (1984)
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.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Approximately two and a half (2.5) months post initial procedure, the patient presented with a limb occlusion.However, the exact date of event is unknown.The physician plans to re-intervene and surgery has been scheduled.As of date, there have been no additional patient sequelae reported.The reporting sales representative observed that the patient's initial computed tomography (ct) had common femoral disease, which is outside the indications of use.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment, the limb occlusion event is unconfirmed.Procedure related, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records/ images available for review.The final patient status was reported being stable post the secondary endovascular procedure.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Approximately two and a half (2.5) months post initial procedure, the patient presented with a limb occlusion.However, the exact date of event is unknown.The physician plans to re-intervene and surgery has been scheduled.As of date, there have been no additional patient sequelae reported.The reporting sales representative observed that the patient's initial ct had common femoral disease, which is outside the indications of use.Additional information: a intervention was completed (b)(6) 2019.The physician elected to implant a ovation ix iliac limb to resolve this event.The final patient status was reported being stable post the secondary endovascular procedure.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9461206
• Report Number: 3008011247-2019-00178
• Device Sequence Number: 3078614
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428120J1
• UDI-Public: +M701TVIL1428120J1/$$3210808FS07261834Z
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: 08/08/2021
• Device Model Number: TV-IL1428120-J
• Device Catalogue Number: TV-IL1428120-J
• Device Lot Number: FS072618-34
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 08/16/2020
• 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 ILIAC LIMB FS082718-29; OVATION IX MAIN BODY FS071019-15
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 73 YR