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

Model Number	TV-AB2680-J
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/30/2018
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 originally implanted with an ovation main body, extender, and three (3) iliac limbs on (b)(6) 2018.During a follow-up non-con ct scan, a type 1a endoleak was observed.Endologix became aware of a complaint against our device on (b)(6) 2018.The patient is doing well, and a follow-up contrast ct scan is planned for 2 months from now.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported event: intra-operative type ia endoleak.The complaint is most likely user related (off-label); case planning was performed with non-contrasted ct which most likely is the contributing factor for this event.Additionally there was evidence to reasonably support infolding of the first sealing ring.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be in a stable condition and will be on surveillance.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.Correction: (b)(4).Additional information: (b)(4).

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7503908
• Report Number: 3008011247-2018-00092
• Device Sequence Number: 1813747
• Product Code: MIH
• UDI-Device Identifier: M701TVEX161645J1
• UDI-Public: +M701TVEX161645J1/$$3200111FS12141612L
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2020
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-EX161645-J
• Device Lot Number: FS091917-62
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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 FS010418-64; OVATION-ILIAC LIMB - LOT FS030218-07; OVATION-ILIAC LIMB - LOT FS040617-16; OVATION-MAIN BODY - LOT FS091917-62
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR