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

Model Number	TV-AB2380-J
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Post polymer fill of the aortic body stent graft, the patient experienced hypotension and was successfully treated for an anaphylactic reaction per the device ifu.A palmaz (non- endologix) stent was placed at the level of the sealing rings.The final angiogram confirmed the aneurysm was excluded with no observation of an endoleak of any type present.The procedure concluded without further incident.The patient will continue to be monitored.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several attempts were made to obtain medical records and medical images but no response was received for medical images and patient authorization is required for medical records.As such, procedure related harms, event determination, off label conditions, related patient harms and patient disposition could not be assessed.The reported intraoperative hypotension and successfully treated for an anaphylactic reaction per the device ifu is most likely device related due to a suspected polymer leak.On (b)(6) 2018, endologix issued a field safety notice (fs-0009) regarding the risk of polymer leak events with the ovation ix aortic body stent graft.On (b)(6) 2020, endologix issued a follow-up safety update (fs-0012) reaffirming treatment recommendations for patients who experience a polymer leak during implantation and providing updated information on the current rate of polymer leaks, the rate of clinical harms and root cause.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.

• Brand Name: OVATION IX
• Common Device Name: AORTIC MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8529578
• Report Number: 3008011247-2019-00064
• Device Sequence Number: 1629247
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3220115FS112818284
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 01/15/2022
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS112818-28
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FSN-0009, FSN-0012
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATIION IX ILIAC LIMB - LOT FS080618-59; OVATIION IX ILIAC LIMB - LOT FS092718-48; OVATION PRIME FILL POLYMER - LOT FF102418-02
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR