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

Model Number	TV-AB3480-E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation prime abdominal aortic aneurysm stent.Approximately five (5) years post initial procedure, the patient presented with a type ia endoleak and aneurysm sac enlargement (unknown diameter).The physician plans to re-intervene but surgery has not been scheduled.The physician will continue to monitor the patient.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Clinical assessment of the reported event was unable to be completed due to a lack of receipt of relevant medical records and / or imaging.Requests were made; however there was no response form the hospital.As such, event determination, off label conditions, related patient harms and patient disposition could not be assessed.The device remains implanted; therefore, no device evaluation was completed.The manufacturing lot evaluation confirmed all devices met specifications prior to release.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: h6: result code ¿ remove 3233.H6: conclusion code ¿ remove 11.

• 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: 9751716
• Report Number: 3008011247-2020-00032
• Device Sequence Number: 2573679
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480E1
• UDI-Public: +M701TVAB3480E1/$$3170717FS060314174
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 07/17/2017
• Device Model Number: TV-AB3480-E
• Device Catalogue Number: TV-AB3480-E
• Device Lot Number: FS060314-17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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 PRIME ILIAC LIMB FF101314-01; OVATION PRIME ILIAC LIMB FS050814-29
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR