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

Model Number	TV-AB2080-J
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Not Applicable (3189)
Date of Event	06/26/2020
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).An intraoperative 1a endoleak was identified at the end of the procedure.The physician elected to monitor the patient and will re- evaluate at the 30 day follow up.
Additional Manufacturer Narrative
It was reported intraoperative type 1a endoleak appears have resolved on its own with no intervention.Therefore there was no patient harm or device failure.A complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.Corrections: b5: describe event or problem h6: patient code: remove code 1924.H6: device code: remove code 3190.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).An intraoperative 1a endoleak was identified at the end of the procedure.The physician elected to monitor the patient and will re- evaluate at the 30 day follow up.Additional information: it was reported intraoperative type 1a endoleak appears have resolved on its own with no intervention.Therefore there was no patient harm or device failure.A complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.

• 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: 10320965
• Report Number: 3008011247-2020-00080
• Device Sequence Number: 14323830
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2080J1
• UDI-Public: +M701TVAB2080J1/$$3230415FS04142001T
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/26/2020

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: 04/15/2023
• Device Model Number: TV-AB2080-J
• Device Catalogue Number: TV-AB2080-J
• Device Lot Number: FS041420-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 09/20/2020
• 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: ILIAC LIMB LOT FS032320-38; ILIAC LIMB LOT FS032420-33; POLYMER LOT FF081219-02; ILIAC LIMB LOT FS032320-38; ILIAC LIMB LOT FS032420-33; POLYMER LOT FF081219-02
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR