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

Model Number	TV-AB2980-J
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/14/2019
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.At the final scan an endoleak was detected at the location of the left iliac limb and the aortic main body; suspected type iiia endoleak.A decision was made to balloon both limbs which improved the endoleak however, did not successfully resolve it.The physician elected to implant an atrium stent in the aortic body over the junction of the left iliac limb however, the endoleak remained.An additional implant was placed; visipro, into the right and an endoleak was still detected.The physician concluded the case with an endoleak present.The patient will continue to be monitored.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported the type iiia endoleak was unconfirmed.Device, user, procedure or anatomy relatedness of this event could not be determined.Additionally, there was a possible type ii endoleak (non-device related) from the internal mesenteric artery as well as a possible dual limb placement noted from the non-diagnostic angiogram movies available.Additional imaging would be necessary to determine if either of these conditions contributed to the reported event.Also, the measurement of the left iliac artery was off label of 5.3mm (should be 8-25mm).The final patient status was discharged home on post-operative day 6 following the endovascular procedure as well as a jejunostomy tube placement for esophageal cancer (pre-existing condition).
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.At the final scan an endoleak was detected at the location of the left iliac limb and the aortic main body; suspected type iiia endoleak.A decision was made to balloon both limbs which improved the endoleak however, did not successfully resolve it.The physician elected to implant an atrium stent in the aortic body over the junction of the left iliac limb however, the endoleak remained.An additional implant was placed; visipro, into the right and an endoleak was still detected.The physician concluded the case with an endoleak present.The patient will continue to be monitored.Subsequent to the initial report, clinical assessment determined there was a possible type ii endoleak (non-device related) from the internal mesenteric artery as well as a possible dual limb placement noted from the non-diagnostic angiogram movies available.Additionally, the left iliac artery measurement of 5.3mm was off label (per the ifu it should be 8-25mm).

• 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: 9036968
• Report Number: 3008011247-2019-00139
• Device Sequence Number: 16590499
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3220716FS07101925B
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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: 07/16/2022
• Device Model Number: TV-AB2980-J
• Device Catalogue Number: TV-AB2980-J
• Device Lot Number: FS071019-25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 07/27/2020
• 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: ATRIUM STENT.; OVATION CUSTOM SEAL FILL POLYMER.; OVATION IX ILIAC LIMB (2).; VISIPRO STENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR