MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR) 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	05/16/2019
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.A suspected polymer leak may have occurred however, the patient remained stable with no hypotensive reaction or treatment.A palmaz stent was implanted and the aneurysm was successfully excluded.The patient will continue to be monitored.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The returned delivery system is not applicable/germane to the reported hypotension due to a suspected polymer leak as outlined within the endologix field safety notice (fsn), fs-0012.Technical and procedural factors of the user (e.G.Use of the cross over lumen before polymer fill, catheter manipulation) are not causative for the majority of polymer leaks as was previously communicated, subsequently an evaluation of the returned delivery system is no longer warranted.At the completion of the clinical assessment, the patient experienced hypotension and was successfully treated for an anaphylactic reaction per the device ifu due to a suspected polymer leak was confirmed.This event is most likely device related as identified in field safety notice (fs-0012), the root cause for most polymer leaks is a material weakness adjacent to the polymer fill channel which may become compromised during pressurization with liquid polymer.Since this device remains implanted, endologix is unable to conduct product evaluation to conclusively ascertain root cause.However, based on the investigation associated with the fsn this is the most likely cause associated with this event.The final patient status was reported being stable.On 06aug2018, endologix issued a field safety notice (fs-0009) regarding the risk of polymer leak events with the ovation ix aortic body stent graft.On 06may2020, 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.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Post polymer fill of the aortic body stent graft, the patient experienced hypotension due to a suspected polymer leak and was successfully treated for an anaphylactic reaction per the device ifu.A palmaz (non- endologix) stent was required but no endoleak was identified.At the conclusion of the procedure the aneurysm was excluded.The patient will continue to be monitored.

• 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: 8697929
• Report Number: 3008011247-2019-00095
• Device Sequence Number: 19401665
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3220320FS03151902Z
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/16/2019

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: 03/20/2022
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS031519-02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 08/30/2020
• 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: OVATION IX ILIAC LIMB - FS100818-23; OVATION IX ILIAC LIMB - FS102318-10; OVATION PRIME POLYMER - FF102418-03
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR