MAUDE Adverse Event Report: ENDOLOGIX INC. OVATION PRIME; ILIAC LIMB

Model Number	TV-AB2680-E
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Stenosis (2263); No Information (3190)
Date of Event	03/01/2016
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 implanted with an ovation main body and two (2) iliac limbs on 04 jun 2015.The secondary case for this patient was completed on 15 nov 2016 for an unknown reason and the patient was implanted with an ovation extender.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; a secondary procedure.Additional findings include el1b lcia; sac growth.The most likely cause of the distal loss of seal was the close proximity of left hypogastric to the inferior stent margin of the left common iliac stent.Procedure related harms were not detected.The patient was discharged home in stable on the first post operative day.To date there have been no reports of further negative patient sequalae.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.These types of events will be monitored and trended as part of the quality system.Correction: (b)(4).

• Brand Name: OVATION PRIME
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7444238
• Report Number: 3008011247-2018-00062
• Device Sequence Number: 2053266
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680E1
• UDI-Public: +M701TVAB2680E1/$$3180325FS020915433
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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: Physician
• Device Expiration Date: 03/25/2018
• Device Model Number: TV-AB2680-E
• Device Catalogue Number: TV-AB2680-E
• Device Lot Number: FS020915-43
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2016
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 06/14/2018
• 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-ILIAC LIMB - LOT FS092214-48; OVATION-ILIAC LIMB - LOT FS102214-03; OVATION-MAIN BODY - LOT FS020915-43
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR