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

Model Number	TV-AB2380-J
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994); Thrombus (2101); Aortic Dissection (2491)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An ovation ix abdominal stent graft system and two additional ovation ix iliac limb extensions were implanted to treat an abdominal aortic aneurysm.Approximately nineteen days post op, the patient presented to the emergency department with pain in back, legs and abdomen.Ct revealed an occluded ovation graft from the rings down and filled with thrombus as well as a kink in the graft below the rings.The patient was also diagnosed with an aortic dissection located above the main body crown, this is also the location of an aortic intramural hematoma.Patient was sent to the operating room for re-intervention.Bi-lateral cutdowns were performed, a thrombectomy of the graft was done to remove the thrombus.Three non-endologix bare metal stents were implanted to repair the kink in the graft.Flow was restored and kink resolved.Patient condition was reported as stable post re-intervention.Patient will return at a later date to repair the dissection.
Additional Manufacturer Narrative
An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made and denied response were received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The review of manufacturing lot confirmed all devices met specifications prior to release.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.Results codes - 3233 removed, correction.Conclusion codes - 11 removed, correction.

• 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: 8372232
• Report Number: 3008011247-2019-00026
• Device Sequence Number: 11063700
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3210924FS09191832D
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/02/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS091918-32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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 IX ILIAC LIMB (LN FS080918-26); OVATION IX ILIAC LIMB (LN FS080918-47); OVATION IX ILIAC LIMB (LN FS081418-31); OVATION IX ILIAC LIMB (LN FS101318-36)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR