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

Model Number	TV-AB2380-J
Medical Device Problem Codes	Leak/Splash (1354); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
The patient was previously implanted with an ovation ix sealing system to treat an abdominal aortic aneurysm (aaa).Approximately two (2) years post initial implant, a type ib endoleak from the limb evidenced by contrast jetting from the limb into the aaa sac was discovered by an ultrasound.An angiogram will be performed to confirm in december.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following observations: the type ib endoleak is refuted but rather, there was a type ia endoleak with sac growth by 5mm.The event is most likely device-related.Procedure-related harms included a type ii endoleak.The final patient status could not be determined, however, the patient was reported stable and awaiting a diagnostic angiogram.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Concomitant medical products and therapy dates - remove fs071216-09 device code - remove 1354 result code - remove 3233 conclusion code - remove 11.
Event or Problem Description
Additional information received per clinical assessment refuting the reported type ib endoleak and rather, a type ia and type ii endoleaks with aneurysm enlargement were confirmed present at the time of the event.

• 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: 8166980
• Report Number: 3008011247-2018-00256
• Device Sequence Number: 1903027
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418140J1
• UDI-Public: +M701TVIL1418140J1/$$3191103FS05171611N
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

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: 11/10/2019
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-IL1418140-J
• Device Lot Number: FS071216-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 04/19/2019
• 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 IX ILIAC LIMB (LN FS060816-14); OVATION IX MAIN BODY (LN FS071216-09); OVATION IX-ILIAC LIMB:FS051716-11
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 86 YR