MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; EXTENDER

Model Number	TV-EX282845-J
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Off-Label Use (1494)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An afx bifurcated stent graft and ovation ix iliac limb stent graft were implanted to repair a previously placed afx bifurcated stent graft and suprarenal aortic extension.Approximately 1 month after the re-intervention, the patient returned with back pain.The patient was diagnosed with a type iiib endoleak of the ovation limb.The physician elected to re-intervene by placing a gore device, successfully resolving the endoleak.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the compromised stent graft integrity was found to be unknown/undetermined due to the lack of medical records and imaging surrounding the event, however, the use of an ovation ix extension with an afx main body stent is considered off-label usage.The procedure related harms and final patient disposition could not be ascertained due to a lack of medical information surrounding the repair event, however, there have been no additional patient sequelae reported.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.Codes: (b)(4).

• Brand Name: OVATION IX
• Common Device Name: EXTENDER
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7117223
• Report Number: 3008011247-2017-00107
• Device Sequence Number: 19150562
• Product Code: MIH
• UDI-Device Identifier: M701TVEX282845J1
• UDI-Public: +M701TVEX282845J1/$$3200803FS072417162
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017

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: 08/03/2020
• Device Model Number: TV-EX282845-J
• Device Catalogue Number: TV-EX282845-J
• Device Lot Number: FS072417-16
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 04/12/2018
• 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: AFX, A34-34/C100-O20; AFX, BA25-90/I16-30; AFX2, BEA28-90/I16-30
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR