MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ABDOMINAL STENT GRAFT SYSTEM

Model Number	TV-AB2680-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/23/2021
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 3.5 years post initial implant during a routine follow-up, a computed tomography (ct) scan revealed an endoleak of indeterminate origin.The patient was reported as being stable and an intervention has been scheduled.
Additional Manufacturer Narrative
Type ii endoleaks are anatomy related events and are not caused or contributed by the device.A complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.Please remove this mdr from your system.Corrections: b5: describe event or problem.G4: date of received by manufacturer.H6: patient code: remove code 1924.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).Approximately 3.5 years post initial implant during a routine follow-up, a computed tomography (ct) scan revealed an endoleak (indeterminate origin).A computed tomography angiography (cta) scan will be performed on (b)(6) 2021 to identify the type of endoleak.The patient was reported as being stable.Additional information: the reported endoleak of indeterminate origin was identified as a type 2 endoleak.A type 2 endoleak is anatomy related and not related to the device therefore no device failure has occurred.This event is no longer reportable to the fda.A complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.Please remove this mdr from your system.

• Brand Name: OVATION IX
• Common Device Name: ABDOMINAL STENT GRAFT SYSTEM
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 11507604
• Report Number: 3008011247-2021-00020
• Device Sequence Number: 3932471
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3200721FS051617096
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 07/21/2020
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS051617-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 03/24/2021
• 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 FS060215-40; OVATION IX ILIAC LIMB FS082616-15; OVATION PRIME FILL POLYMER FF010317-01; OVATION IX ILIAC LIMB FS060215-40; OVATION IX ILIAC LIMB FS082616-15; OVATION PRIME FILL POLYMER FF010317-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR