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

Model Number	TV-IL1410160-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Occlusion (1984); No Consequences Or Impact To Patient (2199)
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; initial procedure included coiling with covering of the right-side hypogastric artery due to an aneurysmal iliac and tortuosity of both iliacs.Approximately nine (9) months post initial procedure, the patient presented with a possible limb flow reduction and high velocity, monophasic (occlusion) of the right limb detected by ultrasound.However, the exact date of event is unknown.The physician will continue to monitor the patient.As of date, there have been no additional patient sequelae reported.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent; initial procedure included coiling with covering of the right-side hypogastric artery due to an aneurysmal iliac and tortuosity of both iliacs.Approximately nine (9) months post initial procedure, the patient presented with a possible limb flow reduction and high velocity, monophasic (occlusion) of the right limb detected by ultrasound.However, the exact date of event is unknown.The physician will continue to monitor the patient.As of date, there have been no additional patient sequelae reported.Subsequent to the initial report, clinical assessment determined there was no visible flow reduction or occlusion observed on the computerized tomography scan from (b)(6) 2019; therefore, there was no device malfunction.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported possible limb flow reduction and occlusion of the right limb was refuted rather there is no visible flow reduction or occlusion observed on the computerized tomography scan from (b)(6) 2019.There is no device malfunction; however, the coils and intentionally covered right internal iliac artery at the index.The final patient status was reported being monitored.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.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.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 8876316
• Report Number: 3008011247-2019-00126
• Device Sequence Number: 2537153
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1410160J1
• UDI-Public: +M701TVIL1410160J1/$$3210515FS05141846N
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 05/15/2021
• Device Model Number: TV-IL1410160-J
• Device Catalogue Number: TV-IL1410160-J
• Device Lot Number: FS051418-46
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 07/29/2020
• 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 EXTENDER: FS121415-38.; OVATION IX ILIAC LIMB: FS050418-09.; OVATION IX MAIN BODY: FS061118-13.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR