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

Model Number	TV-AB2380-J
Medical Device Problem Codes	Leak/Splash (1354); Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/05/2018
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
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.It was noted that the patient was outside the indications for use due to a short neck; however, the physician elected to treat the patient the patient by placing the stent graft higher than recommended.The final angiogram showed the presence of a type ia endoleak that could not be resolved following ballooning.Upon an attempt to place a non-elgx balloon expandable stent, the aortic body stent graft was displaced distal ~4mm upon deployment of the stent, and the type ia endoleak remained.Bilateral renal stents were placed (renal snorkel), followed by the placement of an aortic cuff (gore) which did not resolve the leak.The endoleak was confirmed the following day via ultrasound evidenced by contrast entering the sac.A secondary intervention is planned at a later date to snorkel the sma and place an additional cuff to resolve the leak.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events of a type 1a endoleak and the non-endologix stents at the bilateral renal artery.This event is mostly user and anatomy related due to the off label neck anatomy 90° (ifu states -infrarenal aortic angle should be
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.It was noted that the patient was outside the indications for use due to a short neck; however, the physician elected to treat the patient the patient by placing the stent graft higher than recommended.The final angiogram showed the presence of a type ia endoleak that could not be resolved following ballooning.Upon an attempt to place a non-elgx balloon expandable stent, the aortic body stent graft was displaced distal ~4mm upon deployment of the stent, and the type ia endoleak remained.Bilateral renal stents were placed (renal snorkel), followed by the placement of an aortic cuff (gore) which did not resolve the leak.The endoleak was confirmed the following day via ultrasound evidenced by contrast entering the sac.A secondary intervention is planned at a later date to snorkel the sma and place an additional cuff to resolve the leak.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.Additional information: subsequent to the initial report, additional information was received, reporting that re-intervention was performed on an unknown date.Snorkeling was done with a non-endologix device (gore) and the type ia endoleak was sealed.

• 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: 8136073
• Report Number: 3008011247-2018-00250
• Device Sequence Number: 16565596
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3210717FS071318033
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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: Health Professional
• Device Expiration Date: 07/17/2021
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS071318-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR