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

Model Number	TV-AB2680-J
Medical Device Problem Codes	Component Incompatible (1108); Off-Label Use (1494); Difficult to Advance (2920)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/22/2019
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.The physician experienced resistance during advancement of the aortic body delivery system through the left common iliac artery.The physician elected to implant a bes at the proximal left common iliac artery below the aortic bifurcation.The aortic boy delivery system was tracked through the bes device however, the bes was dislodged and displaced upward on the aortic body delivery sheath.The physician unsheathed the aortic body stent graft, the bes lodged on the distal portion of the ab.Polymer fill was completed however, the contralateral limb could not be visualized.A decision was made to implant a bard covered stent at the proximal edge of the ipsilateral limb.At the conclusion of the case, an intra-operative type i endoleak was present.The patient will continue to be monitored.
Additional Manufacturer Narrative
Based on the description of the event and information available, the clinical assessment could not confirm the reported events.The pre-case computed tomography revealed bilateral concomitant use with non-endologix products which is outside the indications for use and most likely contributed to the reported events.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.(b)(4).

• Brand Name: OVATION IX
• Common Device Name: AORTIC MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9092332
• Report Number: 3008011247-2019-00142
• Device Sequence Number: 2332608
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3220730FS07261909D
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: 07/30/2022
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS072619-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 11/15/2019
• 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 CUSTOM SEAL FILL POLYMER; OVATION IX ILIAC LIMB
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR