MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; ILIAC LIMB

Model Number	TV-IL1418160-J
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	04/04/2019
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 was implanted to treat an abdominal aortic aneurysm.Approximately two (2) years post initial procedure, during coiling of a type 2 endoleak with sac growth (non-device related failure) a possible type 3b endoleak of the left limb was identified.An angiogram was performed; however, inconclusive.The physician elected to reline the original limb with another ovation ix limb.The subsequent angiogram showed conclusively that the possible type 3b endoleak was resolved.Reportedly, the patient was fantastic post re-intervention and was to be discharged the morning after.
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 reported type iiib endoleak is refuted and rather, it was a type ii endoleak.The secondary endovascular procedure is confirmed.The complaint is most likely anatomy-related due to the type ii endoleak from the inferior mesenteric artery; there is no known device malfunction.The procedure-related harms identified was the type ii endoleak.The final patient status was reported as being stable.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.This is no longer a reportable event to the fda.(b)(4).
Event or Problem Description
Additional information received per clinical assessment refuting the reported type iiib endoleak, and confirming only a type ii endoleak.This is no longer a reportable event to the fda.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8567039
• Report Number: 3008011247-2019-00071
• Device Sequence Number: 19460562
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418160J1
• UDI-Public: +M701TVIL1418160J1/$$3191017FS03121615Q
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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: 10/17/2019
• Device Model Number: TV-IL1418160-J
• Device Catalogue Number: TV-IL1418160-J
• Device Lot Number: FS031216-15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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: 87 YR