MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; MAIN BODY

Model Number	TV-AB2680-J
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/06/2020
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.During the initial implant procedure, the proximal markers of the main body were deployed slightly low of the target landing zone at the left renal ostium.Upon conclusion of the procedure, the final imaging detected a type ia endoleak around the renals on the patient's right side.The physician elected to treat the intraoperative endoleak by additionally implanting a palmaz stent, after which the majority of the leak disappeared.The patient was reportedly stable when leaving the operating room.The physician will continue to monitor the patient and believes the endoleak will self-resolve within a month of the procedure.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported intraoperative type 1a endoleak and malposition of the device was unconfirmed due to a lack of the relevant medical information as only the pre computerized tomography was provided.Device, user, procedure or anatomy relatedness of this event could not be determined due to a lack of the relevant medical information.The final patient status was reported being stable.The device remains implanted; therefore, no device evaluation was completed.The manufacturing lot evaluation confirmed all devices met specifications prior to release.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.Corrections: h6: result code ¿ remove 3233, h6: conclusion code ¿ remove 11.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9673017
• Report Number: 3008011247-2020-00013
• Device Sequence Number: 16841865
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3221120FS111819295
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 11/20/2022
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS111819-29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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 FS111319-13; OVATION IX ILIAC LIMB FS120718-59; OVATION IX ILIAC LIMB FS111319-13; OVATION IX ILIAC LIMB FS120718-59
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR