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

Model Number	TV-IL1428100-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
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 the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, the patient presented to the emergency room with back and abdominal pain.A computed tomography (ct) identified a type 1b endoleak on the right side.The patient was transferred to another hospital and an intervention was completed.The physician elected to implant two (2) additional ovation ix limbs and hypogastric coil embolized to resolve this event.The patient was reported as stable.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several attempts were made to obtain medical records and denied response was received.As such, event determination, off label conditions, related patient harms and patient disposition could not be assessed.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 event and similar events in the event further investigation is needed.

• 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: 10192942
• Report Number: 3008011247-2020-00074
• Device Sequence Number: 13680057
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428100J1
• UDI-Public: +M701TVIL1428100J1/$$3180224FS11241452K
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 02/24/2018
• Device Model Number: TV-IL1428100-J
• Device Catalogue Number: TV-IL1428100-J
• Device Lot Number: FS112414-52
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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: AORTIC MAIN BODY, LOT FS012516-36; ILIAC LIMB, LOT FS121114-10; POLYMER, LOT FF011216-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR