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

Model Number TV-AB2080-J

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Not Applicable (3189)

Event Date 06/26/2020

Event Type  Injury  

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 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.

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 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
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10320965
• MDR Text Key: 200251465
• Report Number: 3008011247-2020-00080
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2080J1
• UDI-Public: +M701TVAB2080J1/$$3230415FS04142001T
• Combination Product (y/n): N
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 09/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Other
• Patient Age: 67 YR