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

Model Number	TV-AB2680-J
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/23/2019
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
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).An intraoperative type ia endoleak was identified.The physician elected to balloon at the level of the sealing rings however, the endoleak remained.A decision was made to conclude the case and continue to monitor the patient.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type ia endoleak was confirmed.A definitive root cause for the type ia endoleak could not be confirmed; however, the calcium noted at the first sealing ring limited good apposition.The procedure related harms for the event could not be determined.The report of an intraoperative type ia left untreated and secondary endovascular procedure to implant a bare metal stent was unconfirmed due to lack of the relevant medical information.This event is user related due to the physician left the endoleak untreated at the initial implant and the calcium noted at the first sealing ring limited the good apposition.The final patient status was reported being stable.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Corrections: g1,2: contact office- name - updated.H6: result code ¿ remove 3233.H6: conclusion code ¿ remove 11.

• 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: 9092657
• Report Number: 3008011247-2019-00145
• Device Sequence Number: 19467233
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3220729FS07231905E
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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: 07/29/2022
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS072319-05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 07/15/2020
• 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: OVATION CUSTOM SEAL FILL POLYMER.; OVATION IX ILIAC LIMB (2).; OVATION CUSTOM SEAL FILL POLYMER; OVATION IX ILIAC LIMB (2)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR