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

Model Number	TV-AB3480-J
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/01/2018
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.Devices remain implanted in patient.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.It was noted that the initial implant was outside the indications of use due to a large neck diameter and pre-existing thrombus.Approximately two (2) months post initial procedure, the patient presented at routine follow-up with a type ia endoleak as detected per ct (computed tomography) scan.The physician plans to re-intervene and 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.It was noted that the initial implant was outside the indications of use due to a large neck diameter and pre-existing thrombus.Approximately two (2) months post initial procedure, the patient presented at routine follow-up with a type ia endoeak as detected per ct (computed tomography) scan.The physician plans to re-intervene and will continue to monitor the patient.As of date, there have been no additional patient sequelae reported.Additional information: secondary procedure was done, coils were placed and the endoleak appears to be resolved.Patient did well and went home.
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.The type ia endoleak event is confirmed.The event is most likely user related due to the off label neck diameter of 30.3mm ( diameter should be 16-30mm) as well as the thick calcifications and significant thrombus.No procedure related harms were identified.The final patient status was discharged on post operative day two home stable following a secondary endovascular procedure with non endologix products.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: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem.H6: method code: remove code 4114.H6: result code: remove code 3233.H6: conclusion code: remove code 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: 9812537
• Report Number: 3008011247-2020-00038
• Device Sequence Number: 13894964
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3210419FS022118498
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 04/19/2021
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS022118-49
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 08/11/2020
• 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 FS030518-37; OVATION IX ILIAC LIMB FS112917-16; OVATION IX ILIAC LIMB FS030518-37; OVATION IX ILIAC LIMB FS112917-16
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 82 YR