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

Model Number	TV-AB3480-E
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/20/2020
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).Approximately seven (7) years post initial procedure, a type 1a endoleak with stent migration (7 to 10 mm) was identified.An intervention has been scheduled.The patient is currently being monitored while waiting for an intervention.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment, the migration is unconfirmed due to a lack of relevant comparative medical imaging.The type 1a endoleakis confirmed by a still photo.Additional findings of a type 2 endoleak (non - device failure) of lumbar occurred.Procedure related harms, device, user, procedure or anatomy relatedness of this event could not be determined with the still photos available for review.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: b5: describe event or problem; 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 seven (7) years post initial procedure, a type 1a endoleak with stent migration (7 to 10 mm) was identified.An intervention has been scheduled.The patient is currently being monitored while waiting for an intervention.Additional information: the type 2 endoleak was discovered during review of the still photos provided.An intervention was completed with the use of ballooning and placing an endurant (non- endologix) stent.A small residual type 1a endoleak was still present at the end of the procedure.

• Brand Name: OVATION PRIME
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10156123
• Report Number: 3008011247-2020-00071
• Device Sequence Number: 835940
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480E1
• UDI-Public: +M701TVAB3480E1/$$3171223FS11101401R
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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: 12/23/2017
• Device Model Number: TV-AB3480-E
• Device Catalogue Number: TV-AB3480-E
• Device Lot Number: FS111014-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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 FF112014-02.; ILIAC LIMB, LOT FS100714-35.; POLYMER, LOT FF112014-02.; ILIAC LIMB, LOT FF112014-02; ILIAC LIMB, LOT FS100714-35; POLYMER, LOT FF112014-02
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR